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Roszdravnadzor letters about rejected drugs. About the information that is mandatory provided to Roszdravnadzor

Summary information of these letters of Roszdravnadzor on the need to withdraw falsified, substandard medicines medicines, the authenticity of which has been questioned

for the period from 07/01/2013 to 07/04/2013

(according to the official website of Roszdravnadzor (www. *****) as of 07/04/2013)

For the period from 07/01/2013 to 07/04/2013 on the official website of Roszdravnadzor (www. *****) posted letters (Table) with information about substandard, falsified drugs and other drugs subject to seizure or suspension of their circulation in the territory Russian Federation.

In accordance with Articles 37, 38, federal law-FZ "On Technical Regulation", in order to prevent substandard and counterfeit drugs from entering circulation, we offer subjects of drug circulation, medical organizations the region to carry out the activities set out in the letters of Roszdravnadzor (the numbers and dates of which are indicated in the Table) and provide information on the work done to the TU of Roszdravnadzor.

Please note that checking for signs of falsification should also be carried out in all series of available drugs, the names of which were previously recognized as falsified. (table).

Information on the measures taken for each fact of detection of drugs. subject to seizure, must be submitted to the technical specifications of Roszdravnadzor on withdrawal or suspension of circulation of such drugs

Table

Medicine	Manufacturer	Series	RF Supplier	Letter from Roszdravnadzor	Reason according to the letter of Roszdravnadzor	Reason for withdrawal
Ammonia solution for external use and inhalation 10% (dark glass bottles) 40 ml		16I-714/13 p. ser. dated 03.07.13		SUSPENSION of the implementation of the PL SERIES for ter. RF (marriage of drugs). "Description", "Packaging".
Arduan liof. for i/v fl. 4 mg No. 5 rl sodium chloride pp 0.9% 2ml amp. No. 5	Gideon Richter			16I-712/13 reviews. ser. dated 03.07.13	WITHDRAWAL uk. LS series COMPLETELY. RZN invites the subjects of medicines circulation to check the availability of UK. a series of drugs and submit to the territorial authority of Roszdravnadzor information on its withdrawal from circulation.	"Recall by the manufacturer of the series" (inf.). The development of serious adverse reactions.
Kalimin 60 H tab. 60mg N100			Medeksport - Severnaya Zvezda Ltd., Omsk region.		SUSPENSION of the implementation of the LP series for ter. RF (marriage of drugs). Roszdravnadzor proposes that the subjects of drug circulation, medical organizations check the availability of the specified series, inform the territorial body of Roszdravnadzor about the results.
Kalimin 60 H tab. 60mg N100	Cloquet PharmaService GmbH Germany			16I-721/13 pr. Ser. dated 04.07.13	SUSPENSION of the implementation of the PL SERIES for ter. RF (marriage of drugs). "Description" *in maps. a pack indicating the M05044 series is enclosed in a fl. indicating the series M02944).
Calcium gluconate-Vial, solution for intravenous and intramuscular injection 100 mg/ml (ampoules) 10 ml №10	North China Pharmaceutical Corporation Co., Ltd. China		PharmAlliance MK LLC, Omsk		SEIZURE and DESTRUCTION uk. PARTY drugs by their owner. SUSPENSION of the implementation of other parties uk. series of drugs (marriage of drugs). Owner - to destroy the batch of drugs. Roszdravnadzor invites the subjects of medicines circulation, medical organizations to check the availability of the indicated series of medicines, the results of which INFORM THE TERRITORIAL AUTHORITY OF ROSZDRAVNADZOR.	SEIZURE and DESTRUCTION uk. BATCH LS owner. SUSPENSION real. other parties of the uk. LS series. "Description" (there is a white precipitate in the ampoules).
Kameton, spray for topical dosing. 30 g, spray bottles (1) - cardboard packs	Samaramedprom		Medeksport - Severnaya Zvezda LLC, Omsk region	02I-704/13 pr. dated 01.07.13	SEIZURE and DESTRUCTION uk. BATCH LS owner. SUSPENSION real. other parties of the uk. LS series. "Marking" (on part of the cardboard packs, the series number is read as 20218, instead of 20213, on the part of the bottles there is no marking of the series number and expiration date).
Ketorol tab. cover captivity. vol. 10 mg 10 pcs (pack. cellular contour) (2)	Dr. Reddy`s Laboratories Ltd India		Oriola LLC, Novosibirsk	16I-722/13 pr. Ser. dated 04.07.13	SUSPENSION of the implementation of the LP series for ter. RF (marriage of drugs). Roszdravnadzor proposes that the subjects of drug circulation, medical organizations check the availability of the specified series, inform the territorial body of Roszdravnadzor about the results.	SUSPENSION of the implementation of the PL SERIES for ter. RF (marriage of drugs). "Residual organic solvents: isopropanol"
Methotrexate-Ebeve injection 10mg/1ml (aip. dark glass) 1 ml №10	Sandoz GmbH Austria			16I-720/13 film dated 04.07.13	PROVIDE information to the Office of the RZN in the Altai kr. RZN invites the subjects of medicines circulation to check the availability of UK. Medicines for withdrawal from circulation, the results of which to inform the ter. organ of the RZN.	Import of a series of drugs to the territory. RF was not carried out (inf.).
Mukaltin tablets 50 mg № 10	Pilot plant "GNTSLS" Ukraine		City Clinical Hospital No. 54 GBU, Moscow	02I-705/13 pr. dated 01.07.13		SEIZURE and DESTRUCTION uk. BATCH LS owner. SUSPENSION real. other parties of the uk. LS series. "Disintegration".
Sodium chloride solution for infusions 0.9% 250 ml, polymer containers				02I-704/13 pr. dated 01.07.13	SEIZURE and DESTRUCTION uk. BATCH LS owner. SUSPENSION real. other parties of the uk. LS series. "Packaging" (the integrity of the container is broken, between the polymer container and the polyethylene bag there is a solution of sodium chloride with dark inclusions).
		02I-704/13 pr. dated 01.07.13
	Farmakon CJSC, Kemerovo region	02I-704/13 pr. dated 01.07.13
Sea buckthorn oil. rectal suppositories 500 mg №10 (blister packs)	Pharmaprim Moldova		SIA International-St. PetersburgCJSC, St. Petersburg	02I-704/13 pr. dated 01.07.13	SEIZURE and DESTRUCTION uk. BATCH LS owner. SUSPENSION real. other parties of the uk. LS series. "Description" (greenish-yellow suppositories). "Authenticity".
	16I-721/13 pr. Ser. dated 04.07.13	SUSPENSION of the implementation of the LP series for ter. RF (marriage of drugs). Roszdravnadzor proposes that the subjects of drug circulation, medical organizations check the availability of the specified series, inform the territorial body of Roszdravnadzor about the results.	SUSPENSION of the implementation of the PL SERIES for ter. RF (marriage of drugs). "Authenticity", "Acidity", "Pack content volume", "Quantification".
Hydrogen peroxide, solution for local and external use 3% (dark glass bottles) 40 ml	Astrakhan pharmaceutical factory				SEIZURE and DESTRUCTION uk. BATCH LS by their owner. SUSPENSION of the implementation of other parties uk. series of drugs (marriage of drugs). Owner - to destroy the batch of drugs. Roszdravnadzor invites the subjects of medicines circulation, medical organizations to check the availability of the indicated series of medicines, the results of which INFORM THE TERRITORIAL AUTHORITY OF ROSZDRAVNADZOR.	SEIZURE and DESTRUCTION uk. BATCH LS owner. SUSPENSION real. other parties of the uk. LS series. "Quantitation".
Sulfacyl sodium bufus eye drops 20% 10 ml, polymer tube-droppers (10), cardboard packs	PFC update			16I-713/13 reviews. ser. dated 03.07.13	Feedback from the manufacturer of drugs COMPLETELY. The subjects of medicines circulation should check the availability of the indicated medicine and provide the territorial body of Roszdravnadzor with information on its withdrawal from circulation.	Reviewed by the manufacturer of drugs in full. Does not correspond to ND "Color".
Activated charcoal tablets 250 mg 10 pcs.			Fitolon Firm LLC, Vladivostok, Primorsky Krai	02I-703/13 pr. dated 01.07.13	SEIZURE and DESTRUCTION uk. BATCH LS by their owner. SUSPENSION of the implementation of other parties uk. series of drugs (marriage of drugs). Owner - to destroy the batch of drugs. Roszdravnadzor invites the subjects of medicines circulation, medical organizations to check the availability of the indicated series of medicines, the results of which INFORM THE TERRITORIAL AUTHORITY OF ROSZDRAVNADZOR.	SEIZURE and DESTRUCTION uk. BATCH LS owner. SUSPENSION real. other parties of the uk. LS series. "Average weight of tablets", "Disintegration", "Microbiological purity",
Phenibut tablets 250 mg 10 pcs. pack. cell contour. (2)	UsolyeSibirsky KhPZ OAO. RUSSIA		Medeksport - Severnaya Zvezda LLC, Omsk region	02I-704/13 pr. dated 01.07.13	SEIZURE and DESTRUCTION uk. BATCH LS owner. SUSPENSION real. other parties of the uk. LS series. "Marking" (on a part of cardboard packs, the series number is read as 20218, the actual series number is 20213).

We remind you that information letters from Roszdravnadzor on the withdrawal from circulation of substandard and falsified drugs, as well as letters on the suspension of drug circulation on the territory of the Russian Federation, in accordance with the requirements of the current legislation, posted on the official website of Roszdravnadzor /www. *****/ In chapter "Drugs - Quality Control of Medicines - Information Letters". This information is the most up-to-date and up-to-date. Since the publication of the letter on the seizure of drugs on the website of Roszdravnadzor, the circulation of such drugs is a violation of Art. 57 of the Law.

Information on the measures taken for each fact of detection of drugs subject to seizure must be provided to the TU of Roszdravnadzor ( in the name of the Head of TU Roszdravnadzor) in the form of a table, within 10 days from the date of posting letters on the website of Roszdravnadzor on the withdrawal or suspension of circulation of such drugs, at the address: Vladimir, st. Gorky d. 58a

In the absence of facts of identification of drugs subject to seizure according to the letters of Roszdravnadzor, quarterly inform the TU of Roszdravnadzor about the work carried out to prevent substandard and falsified drugs from entering circulation.

In order to provide the population of the region with high-quality and safe drugs, the TU of Roszdravnadzor proposes to take comprehensive measures to strictly comply with the requirements established by law on the prohibition of the sale and use of substandard and counterfeit drugs.

№ p/p	Date and letter number Roszdravnadzor	Name LS, release form, dosage	Series	Manufacturer	Name of the organization, in which the drug was found	The supplier	Number of applicants Drugs/number of detected drugs	Taken measures (moving to the quarantine zone, destruction, return owner)

deputy Head of the department for supervision and control in the field of healthcare

In September, 18 drugs were withdrawn from the market, low-quality batches were found in seven drugs, and another 11 lost their registration - check your assortment

Review

Recall of drugs occurs at the initiative of the manufacturer or his representative (in the case of imported drugs), and Roszdravnadzor informs all participants in the drug circulation process about this and recommends what to do. Recommendations for the withdrawal of medicinal products are standard:

What should a manufacturer do?

Provide Roszdravnadzor with information on the withdrawal from circulation of the indicated series of the medicinal product.

What should pharmacies and other subjects of drug circulation do?

Submit to the territorial authority of Roszdravnadzor information confirming the return of the specified batch of the medicinal product to suppliers (manufacturer). Quarantine, suspend vacation.

We have combined all recalled drugs in one table. As a reason, the letters of Roszdravnadzor often indicate “non-compliance of the quality of the drug with the requirements of regulatory documentation” for one or another indicator.

Table 1. Recalled drugs

A drug	Series	Manufacturer	Non-compliance with the indicator
"Thiogamma, film-coated tablets 600 mg 10 pcs., blister packs (3), cardboard packs"	15E138	Dragenofarm Apotheker Puschl GmbH (Germany)	"Dissolution"
"EnceVir Neo for children (Tick-borne encephalitis vaccine culture purified concentrated inactivated sorbed), suspension for intramuscular injection 0.25 ml / dose, ampoules with a point for opening (10), cardboard packs"	T01	JSC NPO Microgen	Development of an adverse reaction
"Olitid, film-coated tablets 600 mg 30 pieces, polymer jars (1), cardboard pack"	2980917	JSC Pharmasyntez	"Microbiological purity"
"Eladon, tablets, prolonged action, film-coated, 80 mg 15 pcs., blister strip packs (2), cardboard packs"	020118, 030418, 040618, 040618, 071018, 081018, 010219, 010118, 050818	JSC "Vertex"
"Fenspiride, syrup 2 mg / ml 150 ml, bottle (1), cardboard packs"	010718, 020718, 030718, 040718, 050818, 060818, 070818, 080818, 090818, 100818, 110818, 120818, 130918, 140918, 151018, 161018, 171018, 181018, 191018, 201018, 211018, 221118, 241118, 231118, 241118, 251118, 261118, 271118, 281118, 291218, 301218, 311218, 321218, 331218, 341218	JSC "Vertex"	Cancel state registration
"Fespalen, syrup 2 mg / ml 150 ml, brown glass bottle (1) complete with a measuring spoon, cardboard packs"	011118, 021118, 031118, 041118, 051118, 061118, 071118, 081118, 091118,	OOO "Ozon"	Cancellation of state registration
"Solution Tablets, dispersible tablets 80 mg 10 pcs., blister strip packs (3), cardboard packs"	011218, 010119	OOO "Ozon"	Cancellation of state registration
"Fespalen, film-coated tablets, 80 mg 30 pcs., blister strip packs (1), cardboard packs"	010317, 020917, 010218, 020218, 030218, 040218, 050218, 060218, 070218, 080218, 090718, 101118, 111218	OOO "Ozon"	Cancellation of state registration
"Fenspiride, film-coated tablets 80 mg 30 pcs., blister strip packs (1), cardboard packs"	010119	OOO "Ozon"	Cancellation of state registration
"Fenspiride, film-coated tablets, 80 mg 10 pcs., blister packs (3), cardboard packs"	011017, 021017, 031017, 010118, 020118, 030118	Nativa LLC Pharmstandard-UfaVITA OJSC	Cancellation of state registration
"Formic acid, substance-liquid"	070219	OJSC "Samaramedprom"	"Quantitation"
Femara	SLX78	(not specified)	Cardboard pack labeling in Turkish
"Visanne" (Visanne)	WES3MR, WES1RV	(not specified)	Lack of labeling in Russian
"Kaletra, film-coated tablets 200 mg + 50 mg 120 pcs., vials (1), cardboard packs"	1077020, 1077021, 1084515, 1084644, 1087248, 1089114, 1089115, 1089116, 1095546	(not specified)
"Fucidin, cream for external use 2% 15 g, aluminum tubes (1), cardboard packs"	А68468		“Marking” (there is no Nycomed logo on the tube and cardboard pack)
"Ketonal, rectal suppositories 100 mg 6 pcs., non-cell packs contour (2), packs of cardboard "	FV5536	Sandoz Ilach Sanai ve Tijaret A.S., Turkey	"Foreign impurities"
"Cardiomagnyl, film-coated tablets 150 mg + 30.39 mg 30 pcs., vials (1), cardboard packs"	01081016	Takeda LLC Pharmaceuticals»	"Content of magnesium hydroxide"
"Firmagon, lyophilisate for solution for subcutaneous injection 80 mg, vials (1) + solvent - water for injection 4.2 ml, syringes (1), adapters (1), injection needles (1), plastic trays (1) , packs of cardboard "	N14606C/Solvent N15109C	Rentschler Biotechnology GmbH, Germany / Ferring GmbH, Germany	"Acetate"

Substandard drugs

The next group in the table is drugs that are withdrawn from circulation after the detection by the territorial bodies of Roszdravnadzor of non-compliance with the regulatory requirements of their individual series during inspections.

What should pharmacies do?

Check for availability of specified series medicines, the results of which to inform the territorial bodies of Roszdravnadzor. Quarantine, suspend vacation.

Table 2. Substandard drugs

A drug	Series	Manufacturer	Non-compliance with the indicator
"Activated charcoal-UBF, tablets 250 mg 10 pcs., packs without cell contour"	461218	OJSC "Uralbiopharm"	"Marking" (there is no registration certificate number on the package)
"Flemoklav Solutab, dispersible tablets 500 mg + 125 mg 4 pcs., blisters (5), cardboard packs"	18E04/62, 18D07/62	Astellas Pharma Europe B.V., Netherlands	"Quantitation"
"Fucidin, cream for external use 2% 15 g, aluminum tubes (1), cardboard packs"	А70883	LEO Laboratories Limited (Ireland)	“Marking” (there is no Nycomed logo on the tube and pack)
"Caffeine-sodium benzoate, solution for subcutaneous injection 200 mg / ml 1 ml, ampoules (10), cardboard packs"	060419	OJSC "Borisov Plant of Medical Preparations", Republic of Belarus	"Quantitative determination of sodium benzoate"
"Glucose, solution for intravenous administration 40% 10 ml, ampoules (10), cardboard packs"	171017	FKP "Armavir biofactory"	"Mechanical inclusions"
"Paracetamol, tablets 200 mg 10 pcs., packs without cell contour"	71016	OAO Irbitsky Chemical Pharmaceutical Plant	"Disintegration"
"Paracetamol-UBF, tablets 500 mg 10 pcs.	650917	OJSC "Uralbiopharm"	"Disintegration"

Cancellation of state registration

In addition to withdrawing specific series from circulation, manufacturers regularly initiate the cancellation of state registration of certain drugs. There can be many reasons for this: the closure of the production site, the results of new clinical trials, the expiration of the primary registration, and so on. The main thing to remember is that the sale of the drug after its exclusion from the register is prohibited and is an offense under Part 2 of Art. 6.33 of the Code of Administrative Offenses "Sale or importation into the territory of the Russian Federation of unregistered medicines."

When reading the table, pay attention not only to the trade name and the owner of the registration certificate, but also to the dosage form of the drug.

Table 3. Drugs that have lost state registration (Suspension of use)

Trade name	INN	Dosage form	R/C holder	R/U number
Sea buckthorn oil	(is absent)	Oil for oral, topical and external use	Katun-Oleum LLC	Р N001308/01 of 04/08/2009
Zavedos	Idarubicin	Capsules, 5 mg, 10 mg, 25 mg	Pfizer Inc, USA	P N011970/01 dated 06/07/2010
Videx	didanosine	Enteric capsules, 125 mg, 250 mg, 400 mg	Bristol-Myers Squibb Company, USA	P N011537/02 dated 05/12/2011
Aptivus	Tipranavir	Capsules, 250 mg	Boehringer Ingelheim International GmbH, Germany	LP-001124 dated 03.11.2011
Atifin	Terbinafine	Tablets, 250 mg	JSC Krka, d.d., Novo Mesto, Slovenia	LSR-000090 dated 31.05.2007
Multi-tabs Teen		Chewable tablets	Ferrosan A/S, Denmark	P N015782/01 of 28.05.2009
Multi-tabs Classic	Multivitamins + Minerals		Ferrosan A/S, Denmark	P N012067/01 of 05/06/2010
Multi-tabs Intensive	Multivitamins + Mineral Salts	Film-coated tablets	Ferrosan A/S, Denmark	P N015485/01 of 04/02/2009
Neupogen	Filgrastim	Solution for intravenous and subcutaneous administration, 30 million U/ml	Amgen Europe B.V., The Netherlands	P N011221/01 dated 02.06.2010
Ivadal	Zolpidem	Film-coated tablets, 10 mg	Sanofi-Aventis France, France	P N014944/01 dated October 27, 2008
Zinaxin	(is absent)	Capsules	Ferrosan A/S, Denmark	P N016143/01 dated November 30, 2009

In early September, the Ministry of Health received 4 more drugs: Artrozilena, Espa-Lipona, Cefepima and attenuated rubella vaccine. Once again, we note that the order of the Ministry of Health concerns the suspension of the application, and not the implementation. Not a word is said about the sale of these drugs in the documents of the ministry. Therefore, the order of the Ministry of Health does not prohibit pharmacies or other organizations from continuing to dispense these drugs.

However, we advise pharmacies to put the listed drugs in a quarantine storage area until further information from the Ministry of Health or Roszdravnadzor becomes available. Thus, the pharmacy will be protected from possible sanctions if the use of a medicinal product sold after the date of issuance of such an order will entail any negative consequences for the patient.

Stay tuned for updates on drug import or production halts (as well as changes in instructions and new drug safety data) in the section, and don't miss our next monthly review listing all withdrawn and recalled drug batches.

INFORMATION MAIL

ON THE ORGANIZATION OF QUALITY CONTROL OF MEDICINAL PRODUCTS IN MEDICAL AND PHARMACY ORGANIZATIONS IN THE KHABAROVSK KRAI

Currently, the range of medicines on the Russian pharmaceutical market is constantly expanding. One of the main tasks of medical and pharmacy organizations is to improve the quality of drug care for the population.

The pharmacy organization bears special responsibility for the goods it sells, because is the end point on the way of drug movement to the consumer, and in this regard, it is important for the pharmacy company to create effective system quality management of drugs from their receipt in the pharmacy to the sale to the population, and providing customers with the purchase of benign medical products.

The purpose of this Letter is to clarify the procedure for working with substandard and counterfeit medicines in the Khabarovsk Territory in accordance with federal laws dated 21.11.2011 No. 323 - FZ "On the basics of protecting the health of citizens in the Russian Federation", dated 12.04.2010. No. 61-FZ "On the circulation of medicines", dated 04.05.11. No. 99-FZ "On Licensing certain types activity”, dated 26.12.08. No. 294-FZ "On the protection of the rights legal entities and individual entrepreneurs in the exercise of state control (supervision) and municipal control”, dated December 29, 2006 No. 258-FZ “On Amendments to Certain Legislative Acts of the Russian Federation in Connection with Improving the Delineation of Powers”, dated December 27, 2002. No. 184-FZ "On technical regulation", which sets out the goals and principles of standardization in the Russian Federation, Decrees of the Government of the Russian Federation dated December 22, 2011 No. 1081 "On licensing pharmaceutical activities", dated September 3, 2010 No. 674 "ON APPROVAL OF THE RULES FOR THE DESTRUCTION OF FAULTY DRUGS , FALSIFIED MEDICINES AND COUNTERFEIT MEDICINES, by order of the Ministry of Health and social development RF dated November 22, 2004 No. 205 “On Approval of the Regulations on the Territorial Authority of the Federal Service for Supervision of Health and Social Development in the Subject of the Russian Federation”, Industry Standard OST 91500.05.0007-2003 “Rules for the Dispensing (Sale) of Medicines in Pharmacy Organizations . Basic Provisions”, approved by the order of the Ministry of Health of the Russian Federation dated 04.03.03. No. 80, dated August 23, 2010 No. 706n “On Approval of the Rules for the Storage of Medicines”, dated December 28, 2010 No. 1221n “On Amendments to the Rules for the Storage of Medicines, approved by Order of the Ministry of Health and Social Development of the Russian Federation dated August 23, 2010 No. 706n ”, Order of the Ministry of Health of the Russian Federation of July 16, 1997 No. 214 “On quality control of medicines manufactured in pharmacies”, instructions on the procedure for accepting products in terms of quantity and quality.

Based on Art. 57. Federal Law No. 12.04.2010 No. 61-FZ "On the circulation of medicines", in accordance with OST 91500.05.0007-2003 "Rules for the release (sale) of medicines in pharmacy organizations. Basic Provisions”, approved by the order of the Ministry of Health of the Russian Federation dated 04.03.03. No. 80 in pharmacy organizations various shapes property a quality management system should be established. The formation of a quality management council, a quality management service or a quality representative is carried out depending on the volume of services provided (sales of goods), organizational structure pharmaceutical organization with the provision of the necessary set of functions.

The quality service implements its functions in accordance with quality standards and their adjustment, taking into account the characteristics of the organization; provides information openness for the consumer; conducts ongoing consultations with consumers, identifying what is needed to improve pharmaceutical care; provides assistance to the consumer, which is ultimately aimed at improving the quality of pharmaceutical products and services.

The Commissioner for Quality is appointed from the management staff of the institution, his job responsibilities are formed.

The authorized representative for quality must be guided by the basics of the legislation on health care, labor, know the regulatory legal framework, regulating pharmaceutical activity, own the theoretical foundations of the conformity assessment system, be able to practically manage and control the quality of medicines, know the organization and technology of all production processes pharmacies.

The authorized representative for quality must be proficient in the methods of "incoming control", which includes checking the drugs in terms of "Description", "Packaging", "Labeling", in a timely manner to identify rejected and counterfeit drugs. To this end, it is necessary:

Have a list of Roszdravnadzor about NLS and FLS. This list has been maintained since 1999. This list is available on the Internet at the website www.farmcontrol.ru.

Timely receive information from Roszdravnadzor on rejected and counterfeit medicines. This information in the form of letters from Roszdravnadzor is posted on the Internet on the website www.roszdravnadzor.ru.

Check quality documents (certificates/declarations of conformity), attachments to shipping documents containing information about the certificate/declaration of conformity. Information about issued declarations/certificates of conformity is posted on the Internet at www.roszdravnadzor.ru in the identification section.

Using these databases, about NLS and FLS, pharmacists and pharmacists of pharmacies, clinics, hospitals, when purchasing and storing medicines, can timely identify such medicines and withdraw them from circulation.

These measures will help protect patients from substandard and counterfeit medicines, which will undoubtedly increase the effectiveness of their treatment.

Heads of medical institutions are obliged to strengthen control over the procedure for purchasing drugs, ensuring quality control of purchased, transported and stored drugs, which should be carried out by employees of pharmacy and medical institutions or other employees responsible for receiving and storing drugs.

Medicinal products that have raised doubts about the quality with the designation: “Rejected during acceptance control” are stored in a pharmacy or medical facility isolated from other medicinal products.

Currently, the issue of product falsification is very acute all over the world, incl. and LP. In addition, the medicinal product passes through a long chain of distributors, and at each stage, damage to drugs is possible, so conducting a full acceptance control is a very important procedure.

in pharmacies and medical institutions it is necessary to carry out an acceptance control and check the incoming goods against the bases of rejected and falsified drugs, identify declarations of conformity, pay close attention to drugs that are most often among the falsified ones.

1. Acceptance control procedures:

Conducting a Compliance Review normative documents by indicators: "Description", "Packaging", "Marking";

The presence of certificates of conformity (declarations of conformity) or information in the shipping documents on certificates (declarations of conformity) for medicines in the institution is checked;

Checking the databases of rejected and falsified medicines is carried out;

Checking the availability of state registration of drugs;

2. Organization of obtaining information on the prohibition of the circulation of medicines:

Availability in the institution of up-to-date information on medicines to be withdrawn from circulation, methods of obtaining it (official website of Roszdravnadzor);

Availability of documents confirming the work with up-to-date information on withdrawal from circulation;

Provision to the Territorial Authority of the Federal Service for Surveillance in Healthcare of information about the work done on the basis of information letters from Roszdravnadzor (promptly - if a counterfeit drug is detected in accordance with the letter from Roszdravnadzor on the seizure of a counterfeit drug or a drug whose authenticity has been questioned, monthly - a summary report and documented information on the withdrawal from circulation (destruction) of the series of medicines indicated in the letters of Roszdravnadzor on the withdrawal from circulation of substandard and counterfeit medicines);

The presence in the sale/use of substandard and falsified medicines indicated in the information letters of Roszdravnadzor, which are posted on the official website of Roszdravnadzor;

The presence of signs of falsification in the drugs available in the institution, indicated in the information letters of Roszdravnadzor.

3. Organization of control over compliance with the expiration dates of medicines (clause 11 of the order of the Ministry of Health and Social Development of the Russian Federation of August 23, 2010 No. 706n “On Approval of the Rules for the Storage of Medicines”):

Availability of an order of the head of the institution on the procedure for keeping records of medicines with a limited shelf life;

Availability of an accounting log (correct execution, completeness and relevance of the information entered);

Accounting is kept on paper or in in electronic format(with obligatory archiving);

Control is carried out by means of: computer technology, rack cards, or a register;

Availability and organization of storage of expired medicines (presence of a "quarantine zone");

The presence of acts on the write-off of medicines with an expired shelf life.

4. Organization of work on withdrawal from circulation, write-off and destruction of medicines prohibited for circulation(Art. 59. Chapter 11 of Federal Law No. 61-FZ of April 12, 2010 “On the Circulation of Medicines”, clause 4., clause 8., clause 10., clause 13. of the Decree of the Government of the Russian Federation of 03.09.2010 No. 674 “On Approval of the Rules for the Destruction of Substandard Medicines, Counterfeit Medicines, and Counterfeit Medicines”):

Availability of information about the organization (s) that has (their) a license to collect, use, neutralize, transport and dispose of waste of I-IV hazard class (organization that destroys medicines);

Availability and organization of storage of medicines to be destroyed;

Availability of acts on the write-off of medicines to be destroyed;

Availability of contracts for the destruction of medicines, as well as acts on their destruction.

Such letters from the regulator are official practical documents recommending market participants (including pharmacies) to take certain actions in relation to these drugs. For this reason, and also due to the massive nature of the September announcements, we decided to make them short review. In the article you will learn which drugs you should pay attention to and what to do with them.

The whole mass of September letters from Roszdravnadzor can be divided into two key groups - “On recall of a drug” and “On receipt of information on the identification of substandard drugs.

Let's start with LS reviews. It should be noted right away that a recall always occurs at the initiative of the manufacturer or his representative (in the case of imported drugs), and Roszdravnadzor only informs all participants in the drug circulation process about this and recommends what to do.

Recall usually one series of the drug, in rare cases - several series. A recall is always preceded by a suspension of implementation, usually announced a few months earlier. The text of the recommendations for recalling the medicinal product is standard:

What should a manufacturer do?

Provide information about the withdrawal from circulation of the specified series of the medicinal product.

What should pharmacies and other subjects of drug circulation do?

Submit to the territorial authority of Roszdravnadzor information confirming the return of the specified batch of the medicinal product to suppliers (manufacturer).

What should the territorial bodies of Roszdravnadzor do?

Ensure control over the withdrawal from circulation of the specified series of the medicinal product.

We have placed all recalled drugs in one table. As a reason, the documents always indicate “non-compliance of the quality of the drug with the requirements of regulatory documentation” for one or another indicator. In the table in the “Reason” paragraph, we indicate only the final indicator, omitting the wording that is repeated in all cases.

A drug	Series No.	Manufacturer	Cause
"Ciprofloxacin-SOLOpharm, eye and ear drops 0.3% 5 ml"	020418	LLC "Groteks"	"Package"
"Activated charcoal-UBF, tablets 250 mg 10 pcs., packs without cell contour"	471217, 110318	OJSC "Uralbiopharm"	"Average tablet weight"
"Citramon P, tablets 10 pcs., packs without cells contour"	130218	OJSC "Uralbiopharm"	"Dissolution"
"Gentamicin, solution for intravenous and intramuscular injection 40 mg / ml 2 ml, ampoules (10), cardboard boxes"	1081017	RUE "Belmedpreparaty"	"Packaging", "Marking"
"Acecardol, enteric-coated tablets 50 mg 10 pcs., blister packs (3), cardboard packs"	340316	JSC Sintez	“Foreign impurities (salicylic acid)"
"Acecardol, enteric-coated tablets 300 mg 10 pcs., blister packs (3), cardboard packs"	1151115	JSC Sintez	"Description", "Foreign matter (salicylic acid)"
	200318	CJSC VIFITECH	"Average weight of tablets", "Disintegration"
"Mukaltin, 50 mg tablets, 10 pcs., non-cell contour packs"	060118	CJSC VIFITECH	"Average tablet weight"
"Ardalon, capsules 100 mg 10 pcs., blister strip packs (1), packs cardboard"	90917	VEROPHARM JSC
"Ardalon, capsules 100 mg 10 pcs., blister strip packs (3), cardboard packs"	70917, 80917, 10218, 20418, 30418	VEROPHARM JSC	In connection with the cancellation of the state registration of the medicinal product and its exclusion from the GRLS
"Ferro-Foilgamma, 10 capsules, blister packs (2), cardboard packs"	16J216	Catalent Germani Eberbach GmbH, Germany/C.P.M. Contract Pharma GmbH and Co.KG, Germany	Initiative of Vervag Pharma LLC, indicator “Quantitative determination. Iron content»
"Novatrizoate, injection solution 760 mg/ml 20 ml, vials (10), cardboard boxes (for hospitals)"	NV0416AD7, NV0616AD7	Novalek Pharmaceuticals Pvt. Ltd., India	Initiative of LLC "Jodas Expoim", indicator "Osmolality (cryoscopic method)"
"Laktofiltrum®, 15 tablets, blister packs (4), cardboard packs"	20118	JSC AVVA RUS	In connection with the investment in the packaging of the drug, instructions for use for another drug

Identification of substandard drugs

The second reason for information letters from Roszdravnadzor is the discovery by the territorial bodies of the regulator during inspections of drugs that do not meet regulatory requirements. Often we are talking only about one series and about relatively “light” violations.
However, in letters federal Service for Supervision in the Sphere of Health Care announces the suspension of the sale of other batches of the indicated series of medicinal products.

What should the territorial bodies of the RZN do?

Ensure control over the withdrawal from circulation and destruction in in due course of the indicated batches of medicinal product.

What should pharmacies do?

To check the availability of the specified series of medicinal products, the results of which to inform the territorial bodies of Roszdravnadzor.

A drug	Series	Manufacturer	Cause
"Vikasol, solution for intramuscular injection 10 mg / ml 1 ml, neutral glass ampoules with a break ring (5), blisters (2), cardboard packs"	010517	OOO "Ellara"	Indicator "Description" (the color of the solution in ampoules is heterogeneous)
"Reopoliglyukin, solution for infusion 10% 400 ml, 450 ml bottles (15), cardboard boxes (for hospitals)"	2440817	JSC "Biochemist"	Indicator "Description" (in terms of bottles solution with white flakes and fibers)
"Antareit, chewable tablets 800 mg/40 mg 6 pcs., blister strip packs (2), cardboard packs"	ECC7020	"Sequel Pharmaceuticals Pvt. Ltd., India	Indicator “Quantitative determination. Magnesium hydroxide"
"FURADONIN AVEXIMA, tablets 50 mg 10 pcs., blister strip packs (2), cardboard packs"	160517	OAO Irbitsky Chemical Pharmaceutical Plant	“Packaging” indicator (one tablet is missing in one blister pack)
"Ascorbic acid, solution for intravenous and intramuscular injection 50 mg / ml 2 ml, ampoules (10), cardboard boxes"	270418	JSC DALHIMFARM	Indicator "Labeling" (for some ampoules, the series number and concentration are partially erased)
"Ammonia, solution for external use and inhalation 10% 40 ml, dark glass bottles	020217 040517	OOO "Hippocrates"	Indicator "Description" (liquid with fine crystalline sediment)
"Glucose, solution for intravenous administration 40% 10 ml, ampoules (10), cardboard packs"	281216	FKP "Armavir biofactory"	“Packaging” indicator (in some ampoules, the surface is covered with a white coating)
"Hawthorn tincture, tincture 25 ml, dark glass bottles (1), packs cardboard"	171017	OJSC "Flora of the Caucasus"	Indicator "Description" (liquid with suspension)
"Activated charcoal, tablets 250 mg 10 pcs., packs without cell contour"	480418	JSC "Irbit Chemical-Pharmaceutical Plant"	Indicator "Average weight of tablets"
"Captopril, tablets 0.05 g 10 pcs., blister packs (4), cardboard packs"	1331016	PRANAPHARM LLC	Indicator "Marking" (on cardboard packs there is an unforeseen regulatory documentation indication of storage conditions "... at a temperature not exceeding 25 ° C"; and also instead of the inscription: “Do not use after the expiration date ...” it says: “Do not use after the expiration date ...”)

We invite our readers to analyze their current assortment using the tables from the article. This will help to avoid unpleasant situations with the regulator and continue to work calmly.

Protect yourself and loved ones.

Due to the increasing number of recalls of medicines, we have created for you a constantly updated list of low-quality medicines based on official information from Roszdravnadzor (the body responsible for controlling the medicines sold). Thanks to him, you can avoid buying low-quality goods and keep yourself and your loved ones healthy. Look for the indication of the manufacturer and lot number on the package of the drug.

"SotaGeksal, tablets 80 mg 10 pcs.", manufactured by "Salutas Pharma GmbH", series GA8585.
"Drotaverine, solution for injection 20 mg / ml 2 ml", produced by FKP "Armavir biofactory", series 100716.
"Acecardol, enteric-coated tablets 100 mg 10 pcs.", manufactured by Sintez OJSC, series 940914.
Rinonorm, dosed nasal spray 0.1% 15 ml, manufactured by Merkle GmbH, series S05053.
"Lidocaine, solution for injection 20 m g / ml 2 ml", produced by Slavyanskaya Apteka LLC, series 180615.
"Lizinopril, tablets 5 mg 30 pcs.", produced by Ozon LLC, series 070715.
"Acecardol, enteric-coated tablets 100 mg 10 pcs.", manufactured by Sintez OJSC, series 1371214, 540414.
"Emend, capsules set 125 mg No. 1 + 80 mg No. 2", manufactured by MSD Pharmaceuticals LLC, series L045274, L038452 with secondary packaging marking in Turkish.
Galazolin nasal gel 0.05% 10 g

"Hydrogen peroxide, solution for topical use 3% 100 ml" produced by Iodine Technologies and Marketing LLC, series 1580816.
"Paracetamol-UBF tablets 500 mg 10 pcs.", produced by OJSC "Uralbiopharm", series 440915.
"Alflutop, solution for injection 1 ml", produced by "K.O. Biotechnos S.A., Romania/K.O., Rompharm Company S.R.L., Romania”, series 3450815.
"Oxaliplatin - Ebeve lyophilisate for solution for infusion 50 mg", manufactured by ZAO Sandoz, series EY9765, FD6560, FU2598, FX0333.
"Oxaliplatin - Ebeve lyophilisate for solution for infusion 100 mg", manufactured by Sandoz CJSC, series EP5828, ES3374, FD8469, FE1438, FG9149, FJ6015, FT5084, FV3353.
"Ammonia, solution for external use and inhalation 10% 40 ml", manufactured by Hippocrat LLC, series 090516.
"Ichthyol, ointment for external use 10% 25 g", produced by CJSC "Yaroslavl Pharmaceutical Factory", series 10416.
"Ichthyol, ointment for external use 20% 25 g", produced by CJSC "Yaroslavl Pharmaceutical Factory", series 10516.
Naphthyzinum, nasal drops 0.1% 15 ml, produced by DAB Pharm LLC, series 711115, 370515.
"Folic acid, tablets 1 mg 50 pcs.", manufactured by JSC "Valenta Pharmaceuticals", series 101015.
Nitroxoline-UBF, film-coated tablets 50 mg 10 pcs., produced by OJSC Uralbiopharm, series 421115.
"Streptokinase, lyophilizate for the preparation of a solution for intravenous and intra-arterial administration 1500000 ME", produced by RUE "Belmedpreparaty", series 011115.
"CardiaSK, enteric-coated film-coated tablets 100 mg 30 pcs.", manufactured by CJSC "Canonfarma products", series 100316.
"Ammonia, solution for external use and inhalation 10% 40 ml", manufactured by Hippocrat LLC, series 070516.
"Ofloxacin film-coated tablets 400 mg 10 pcs.", manufactured by Sintez OJSC, series 241214.
"Hofitol, coated tablets 30 pcs." production of "Laboratory Roza-Fitopharma", series VN1466.
Gliatilin, capsules 400 mg 14 pcs., produced by Italfarmaco S.p.A., series 260716, 270716.

"Acecardol enteric-coated tablets 50 mg 10 pcs.", manufactured by Sintez OJSC, series 400316.
"Drotaverin solution for injection 20mg/ml 2ml", produced by FKP "Armavir biofactory", series 070615.
"Aerus, aerosol for inhalation dosed 85 CIE / dose 250 doses", produced by "WAKE, spol.s.r.o.", series A08161.
"Bifidumbacterin, powder for oral and topical use 500 million CFU bifidobacteria / package 0.85 g (30)", produced by CJSC "Partner", series 187-30616.
"Hydrogen peroxide, topical solution 3% 100 ml", produced by Iodine Technologies and Marketing LLC, series 1970916.
"Perindopril-Richter, - tablets 8 mg No. 30", manufactured by Gedeon Richter Poland LLC, series H54012A.
Diclofenac enteric-coated tablets 50 mg 10 pcs., produced by Ozon LLC, series 020315.
"BETAGISTIN, tablets 24 mg 10 pcs.", manufactured by PRANAPHARM LLC, series 100616.
"Genferon Light nasal spray dosed 50 OOOME + 1 mg / dose 100 doses", produced by CJSC "BIOKAD", series 25070316, 25100316.
"Pentoxifylline, a concentrate for the preparation of a solution for intravenous and intra-arterial administration 20 mg / ml 5 ml", manufactured by JSC "Biochemist", series 281214.
"Lidocaine solution for injections 20 mg / ml 2 ml", produced by Slavyanskaya Apteka LLC, series 190615.
Lisinopril tablets 5 mg 30 pcs., produced by Ozon LLC, series 070715.
"Mukosat, solution for intramuscular injection 100 mg / ml 1 ml", manufactured by Sintez OJSC, series 170616, 180616.
"Mukosat, solution for intramuscular injection 100 mg / ml 1 ml", manufactured by Sintez OJSC, series 190616.
"Diclogen gel for external use 1% 30 g", manufactured by "Agio Pharmaceuticals Ltd", series 58245.
Strepsils, lozenges (honey-lemon) 12 pcs.
"Ampicillin, tablets 250 mg 10 pcs.", produced by CJSC "PFC Update", series 60616.
"Fukortsin solution for external use 25 ml", produced by CJSC "Yaroslavl Pharmaceutical Factory", series 40315.
"Bifidumbacterin, powder for oral and topical use 500 ml", produced by CJSC "Partner", series 187-30616.

"Naphthyzine, nasal drops 0.1% 15 ml, vials", produced by DAV Pharm LLC, series 100216.
"De-Nol, film-coated tablets 120 mg 8 pcs.", manufactured by Astellas Pharma Europe B.V., series 343072015, 162112013.
"Sodium chloride, a solvent for the preparation of dosage forms for injections 0.9% 10 ml", manufactured by Grotex LLC, series 351214.
"Acecardol, enteric-coated tablets 100 mg 10 pcs.", manufactured by Sintez OJSC, series 1371214, 540414.
"Ammonia, solution for external use and inhalation 10% 40 ml", produced by Iodine Technologies and Marketing LLC, series 330715.
"Paracetamol-UBF tablets 500 mg 10 pcs.", produced by OJSC "Uralbiopharm", series 190416.
"Herceptin, lyophilisate for the preparation of a concentrate for solution for infusion 440 mg, 440 mg vials (1) / solvent - bacteriostatic water for injection 20 ml", on the packages of which it is indicated "Manufactured by: "Genentek Inc., USA (lyophilisate) / F .Hoffmann-La Roche Ltd, Switzerland”/Packed by ZAO ORTAT, Russia”, series M3680/1/p-l B2092/4.

Kagocel, tablets 12 mg 10 pcs., produced by NEARMEDIC PLUS LLC, series 5040615.
Maalox, chewable tablets 10 pcs., produced by Sanofi-Aventis S.P.A., A802 series.
"Betahistine, tablets 16 mg 10 pcs.", manufactured by PRANAPHARM LLC, series 10216, 40516.
"Linkas BSS, syrup 120 ml", manufactured by "Herbio Pakistan Private Limited", series 2715 039.
"Magnesium sulfate, solution for intravenous administration 250mg / ml 10 ml", manufactured by "Shandong Shenglu Pharmaceutical Co. Ltd., series 140530.
"Cough medicine for children, dry, powder for solution for oral administration 1.47 g", produced by CJSC "VIFITECH", series 030216.
"Amiodarone, tablets 200 mg 10 pcs.", produced by OJSC "Borisov Plant of Medical Preparations", series 3390616.
"Hydrogen peroxide, solution for topical use 3% 100 ml", produced by Iodine Technologies and Marketing LLC, series 1780916.
"Diazolin, dragee 100 mg 10 pcs.", manufactured by OJSC "Marbiopharm", series 90416.
"Diclofenac, solution for intramuscular injection 25 mg / ml 3 ml", manufactured by Ellara LLC, series 060616.
"Mirena, intrauterine therapeutic system, levonorgestrel 20 mcg/24 hours", series TU01976, indicated on the packages by Bayer Oy, Finland.
"Mirena, intrauterine therapeutic system, levonorgestrel 20 mcg / 24 hours", manufactured by BAYER JSC, series TU019TZ with Turkish labeling.

"Ceftriaxone, powder for solution preparation for intravenous and intramuscular injection 1.0 g, complete with solvent 5 ml", manufactured by JSC "Biochemist", series 0140516/0880516, 0150516/0890516.
"Revalgin, solution for injection 5 ml", produced by "Shreya Life Science Pvt. Ltd", SA1463009 series.
"Potassium chloride, solution for injection 7.5% 100 ml", produced by the pharmacy GBUZ LO "Tosnenskaya KMB", series An. 793-94.
"Sodium chloride, solution 10% 150 ml", produced by the pharmacy GBUZ LO "Kirishskaya KMB", series An. 238-238a.
"Sodium chloride, injection 0.9% 300 ml", produced by the pharmacy GBUZ LO "Tosnenskaya KMB", series An. 817-18.
"Essentiale forte N, capsules 300 mg 10 pcs.", manufactured by "A. Nattermann & Sie. GmbH, Germany", series 4K2291, 4K2721.
"Reaferon-ES-Lipint, lyophilisate for suspension for oral administration 250 thousand IU" manufactured by Vector-Medica CJSC, series 01, 02.
"Ultracain D-S forte solution for injection, 40 mg / ml + 0.010 mg / ml (cartridge) 1.7 ml x 100 (cardboard pack)", manufactured by Sanofi Russia JSC.
"Ultracain DS solution for injection, 40 mg/ml + 0.005 mg/ml (cartridge) 1.7 ml x 100 (cardboard pack)", manufactured by Sanofi Russia JSC.

"Avastin, concentrate for the preparation of a solution for infusion 100 mg / 4 ml", manufactured by F. Hoffmann-La Roche Ltd., Switzerland / packed by CJSC ORTAT.
"Exoderil, solution for external use 1% 10 ml", manufactured by "Sandoz GmbH, Biochemistrasse 10", series 13806.
"Cerebrolysin, injection solution 10 ml", manufactured by "EVER Pharma Jena GmbH", series A3HB1 A, A3HD1A, A3NE1A.
"Cerebrolysin, solution for injection 2 ml", produced by "EVER Pharma Jena GmbH", series A3HP1A, A3HS1A.
"Cerebrolysin, solution for injection 5 ml", produced by "EVER Pharma Jena GmbH", series A3DW1A, A3GH1A, A3DZ1A.
"Tax-O-Bid, powder for solution for intravenous and intramuscular administration 1 g", manufactured by Orchid Healthcare (a division of Orchid Chemicals and Pharmaceuticals Ltd.), series 1 9066003 / r-l C 160115.
"Femara, film-coated tablets 2.5 mg", manufactured by Novartis Pharma Stein AG, X0188, X0206 series, labeled and instructions in Turkish.
Amlodipine Zentiva, tablets 5 mg 10 pcs., manufactured by Zentiva K.S., series 3161215.
Chlorprothixene Zentiva, film-coated tablets 50 mg 10 pcs., manufactured by Zentiva K.S., series 3590216.
"Carvedilol Zentiva, tablets 6.25 mg 15 pcs.", manufactured by "Zentiva ks", series 2081215, 2010216.
Lozap plus, film-coated tablets 50 mg + 12.5 mg 15 pcs.
"Milgamma solution for intramuscular injection 2 ml", manufactured by "Solupharm Pharmaceutishe Erzeignisse GmbH", series 14006.
"Paracetamol-UFB, tablets 500 mg 10 pcs.", produced by OJSC "Uralbiopharm", series 190416.
Ruzam, solution for subcutaneous injection 0.2 ml, produced by Ruzam-M LLC, series 040915, 050915, 061215.

"Longidase, lyophilisate for solution for injection 3000 IU", manufactured by NPO Petrovax Pharm LLC, series 161215.
"Vazotenz, coated tablets 50 mg 10 pcs.", manufactured by Actavis JSC, series 166880, 167130.
"Acecardol, enteric-coated tablets 100 mg 10 pcs.", manufactured by Sintez OJSC, series 130115.
Enterodez, powder for oral solution preparation 5 g N.A. Semashko, series 20315.
"Griseofulvin, tablets 125 mg 10 pcs.", manufactured by JSC "Biosintez", series 71015.
"Concor, film-coated tablets 5 mg 25 pcs.", manufactured by Merck KGaA, series 185787.
"Ethyl alcohol, solution for external use and preparation of dosage forms 95% 100 ml", produced by JSC PCPC "Medkhimprom", series 820815.
"SotaGeksal, tablets 160 mg 10 pcs.", produced by CJSC "SANDOZ", series CR8244.
"SotaGeksal, tablets 80 mg 10 pcs.", produced by CJSC "SANDOZ", series FK0449.
"Dopamine, concentrate for solution for infusion 40 mg / ml 5 ml", manufactured by JSC "Biochemist", series 50414.
"Folic acid, tablets 1 mg 50 pcs.", manufactured by JSC "Valenta Pharmaceuticals", series 80915, 90915.
"Acecardol, enteric-coated tablets 100 mg 10 pcs.", manufactured by Sintez OJSC, series 220215.
Naphthyzinum, nasal drops 0.1% 15 ml, produced by DAV Pharm LLC, series 661115.
"Pentoxifylline, a concentrate for the preparation of a solution for intravenous and intra-arterial administration 20 mg / ml 5 ml", manufactured by JSC "Biochemist", series 30116.
“Adsorbed pertussis-diphtheria-tetanus vaccine (DPT-vaccine), suspension for intramuscular administration” U34 series produced by FSUE “NPO Microgen” of the Ministry of Health of Russia (Russia
"Trisol, solution for infusions 400 ml", produced by OAO NPK "ESKOM", series 140516.
"BETAGISTIN, tablets 24 mg 10 pcs.", manufactured by PRANAPHARM LLC, series 70216.
"Dopamine concentrate for solution for infusion 40 mg / ml 5 ml", manufactured by JSC "Biochemist", series 130614.

"Pentoxifylline, solution for injection 20 mg / ml 5 ml", manufactured by OJSC "Borisov Plant of Medical Preparations", series 2131214.
"De-Nol film-coated tablets 120 mg 8 pcs.", produced by CJSC "R-PHARM", series 365082015.
"Activated charcoal tablets 250 mg 10 pcs.", produced by OAO "Irbitsky Khimfarmzavod", series 670515.
"Suprastin, solution for intravenous and intramuscular injection 20 mg / ml 1 ml" manufactured by JSC "Pharmaceutical Plant", series 31A0214, 45C0514.
“Sea buckthorn oil, oil for oral administration, local and external use 50 ml” and “Sea buckthorn oil, oil for oral administration, local and external use 100 ml”, produced by Yantarnoye LLC, series 050216, 070316, 060216, 080316.
Propazine, film-coated tablets 25 mg 10 pcs.
"Highlander bird (Knotweed) grass, chopped grass 50 g", produced by LLC PFC "Fitopharm", series 010215.
"BETAGISTIN, tablets 24 mg 10 pcs.", manufactured by PRANAPHARM LLC, series 60216.
"Lazolvan, syrup 30 mg / 5 ml 100 ml", manufactured by "Boehringer Ingelheim Ellas A.E.", series 144947.
"Sinaflan, ointment for external use 0.025% 15 g", produced by OJSC "Murom Instrument-Making Plant", series 390316.
"Xeloda, film-coated tablets 500 mg 10 pcs.", CJSC "Rosh-Moscow", series X3988B03.
"Perinorm solution for intravenous and intramuscular injection 5 mg / ml 2 ml", manufactured by Inca Laboratories Limited, series E 354OO6.
"De-Nol, film-coated tablets 120 mg 8 pcs.", produced by CJSC "R-Pharm", series 210052015.
"Ofloxacin, film-coated tablets 400 mg 10 pcs.", manufactured by Sintez OJSC, series 210815.
"Citramon P, tablets 10 pcs.", produced by OJSC "Uralbiopharm", series 280316.
Naphthyzinum, nasal drops 0.1% 15 ml, produced by DAV Pharm LLC, series 260415.
"Longidase, lyophilisate for solution for injection 3000 IU vials", produced by NPO Petrovax Pharm LLC, series 161215.

"Ethyl alcohol, concentrate for preparation of a solution for external use and preparation of dosage forms 95% 100 ml", manufacturer of Hippocrates LLC, series 400616.
"Flexen, lyophilisate for the preparation of a solution for intramuscular injection 100 mg", manufactured by "Italfarmaco S.p.A." series 15511/15511.
"Taxacad, concentrate for solution for infusion 6 mg/ml 35 ml", produced by CJSC "BIOKAD", series 06060316.
"Taxacad, concentrate for solution for infusion 6 mg/ml 50 ml", produced by CJSC "BIOKAD", series 06070316.
"Benzyl benzoate, ointment for external use 20% 25 g", produced by CJSC "Zelenaya Dubrava", series 040216.

"Essentiale forte N, capsules 300 mg 10 pcs.", produced by "A. Natermann & Sie. GmbH, Germany", series 4K1751.
"Zoladex, capsule for subcutaneous administration of prolonged action 3.6 mg, syringe applicator with a protective mechanism", AstraZeneca Pharmaceuticals LLC, series MF862.
"Sodium chloride, solution for infusion 0.9% 200 ml", produced by Anzhero-Sudzhensky Chemical and Pharmaceutical Plant LLC, series 280415.
"Potassium permanganate, powder for preparing a solution for external use 3 g", produced by CJSC "PFC Update", series 20416.
Nutriflex 70/180 lipid, emulsion for intravenous administration, 650 ml containers, produced by B. Braun Melsungen AG, series 160338052.
"Senade tablets 13.5 mg 20 pcs.", manufactured by "Cipla Ltd.", series 485031.
“Peppermint leaves, leaves powder 1.5 g, filter bags (20), cardboard packs”, produced by PKF Fitopharm LLC, series 030615, 020216.
"Acecardol, enteric-coated tablets 50 mg 10 pcs.", manufactured by Sintez OJSC, series 60116.
"Latran, solution 2 mg / ml 4 ml", produced by FSUE NPTI "Pharmzashchita", series 170415.

"Ethyl alcohol, a concentrate for preparing a solution for external use and preparing dosage forms 95% 100 ml", manufactured by Hippocrates LLC, series 270516.
"Drotaverine, solution for injection 20 mg / ml 2 ml", produced by FKP "Armavir biofactory", series 030315.
"Zoladex, capsule for subcutaneous administration of prolonged action 10.8 mg", manufactured by Astra3eneca Pharmaceuticals LLC, MS239 series.
"Basigen, solution for infusion 2 mg / ml 100 ml", manufactured by Claris Life Sciences Limited, series C442460.
Diclogen, gel for external use 1% 30 g, produced by Agio Pharmaceuticals Ltd., series 58259.
"Metrolacare, solution for infusion 5 mg / ml 100 ml", manufactured by "La Care Pharma Limited", AMT5004 series.
"Streptokinase, lyophilizate for the preparation of a solution for intravenous and intra-arterial administration 1500000 ME", produced by RUE "Belmedpreparaty", series 061215.
"Hofitol, film-coated tablets 30 pcs.", Produced by "Laboratory Rosa-Fitopharma", series VN1495, VN1496, VN1497, VN1498, VN1499, VN1500, VN1507, VN1508, VN1509.

"Bravelle, lyophilisate for solution preparation for intramuscular and subcutaneous administration 75 IU", manufactured by Ferring GmbH, series K1 8203C.
Suprima-coff, 30 mg tablets 10 pcs., produced by Shreya Life Sciences Pvt. Ltd., X30021, X30022 series.
"Marcain Spinal Heavy, injection 5 mg / ml 4 ml", manufactured by Seneksi, series F0128-1.
"Taurine-SOLOpharm, eye drops 4% 1 ml", produced by LLC "Groteks", series 050316, 060316, 070316.
"Activated charcoal - UBF tablets 250 mg 10 pcs.", produced by JSC "Uralbiopharm", series 240415, 420615.
"Fluifort, syrup 90 mg / ml 100 ml", produced by "Dompe S.p.A", series 158 0715, 165 0815, 166 0815.
"Lidocaine, injection solution 20 mg / ml 2 ml", produced by LLC "Slavyanskaya Apteka", series 200715.
"Paracetamol, suspension for oral administration 120 mg / 5 ml 100 ml", manufactured by Sintez OJSC, series 110116, 1881015.
"Sodium chloride, a solvent for the preparation of dosage forms for injections 0.9% 10 ml", produced by Grotex LLC, series 340115.

"Diazolin, dragee 50 mg 10 pcs.", manufactured by JSC "Pharmstandard-UfaVITA", series 081215.
Glucose, solution for intravenous administration 400 mg/ml 10 ml 160315, 170515, 180515, 190515, 200615, 210615, 220615, 230615, 240615, 250615, 261015, 271015, 281015, 291115, 301115, 311115, 321115, 331115, 341215, 351215, 361215, 371215, 411215, 010316, 020316.
Chondroxide Maximum, cream for external use 8% 50 g, manufactured by Fir Far East (C) Pte Ltd, series A419NM, A420NM, A462NM, A463NM, A480NM.
"Amlodipine-Prana tablets 5 mg 10 pcs.", manufactured by PRANAPHARM LLC, series 100416.
"Novocain solution for injections 5 mg/ml 5 ml, 5 ampoules", produced by Scientific and Production Concern "ESKOM", series 020116.
"De-Nol, film-coated tablets 120 mg 8 pcs.", manufactured by Astellas Pharma Europe B.V., series 401082015, 475102015, 518122014
"Ampicillin, powder for the preparation of a solution for intravenous and intramuscular injection 500 mg", manufactured by Sintez OJSC, series 940515, 550315.
"Benzyl benzoate ointment for external use 20% 25g", produced by CJSC "Zelenaya Dubrava", series 040216.
"Sodium thiopental, powder for the preparation of a solution for intravenous administration 0.5 g" manufactured by Sintez OJSC, series 260815.
"alpha-Tocopherol acetate solution in oil (vitamin E), oil solution for oral administration 10% 20 ml", produced by JSC "Samaramedprom", series 050416.
"Heparin, solution for intravenous and subcutaneous administration 5000 IU/ml in 5 ml bottles", produced by RUE "Belmedpreparaty", series 750914.
"Dexamethasone solution for injection 4 mg / ml, 1 ml", produced by Elfa Laboratories, series OX-184 dated 10.2014.
"Mitomycin-C Kiowa, powder for solution for injection 10 mg", manufactured by "Kowa Hakko Kogyo Co. Ltd", series 651 AEI01.

The following drugs were recalled in July:

"Acyclovir, tablets 400 mg 10 pcs.", produced by Ozon LLC, series 060115, 070115.
"Paracetamol, tablets 500 mg 10 pcs.", produced by CJSC "PFC Update", series 451215.
Sanorin-Analergin, nasal drops 10 ml, produced by Teva Czech Enterprises s.r.o., series 3A0601015, 3A0280415, 3C0870115.
"Lidocaine, solution for injection 20 mg / ml 2 ml", manufactured by Groteks LLC, series 1271015, 160116.
"Lidocaine, injection solution 20 mg / ml 2 ml", produced by LLC "Slavyanskaya Apteka", series 220815.
"Cardioxipin, solution for infusion 5 mg / ml 100 ml", manufactured by JSC "Biosintez", series 10715.
"Glucose, solution for intravenous administration 400 mg / ml 10 ml", manufactured by Groteks LLC, series 100315.
"Biseptol 480, concentrate for solution for infusion (80 mg + 16 mg) / ml 5 ml", manufactured by Warsaw Pharmaceutical Plant Polfa JSC, series O6AE 1213.
"Cefbactam, powder for the preparation of a solution for intravenous and intramuscular injection 1 g + 1 g", produced by Protech Biosystems Pvt.Ltd, series RT-1505.
"Metrolacare, solution for infusion 5 mg / ml 100 ml", manufactured by "La Care Pharma Limited", AMT5001 series.

Validol, sublingual tablets 60 mg 10 pcs.
"Suprastin, solution for intravenous and intramuscular injection 20 mg / ml 1 ml", manufactured by OJSC "Pharmaceutical Plant", series T1A1113, TOA1113, 14A0114, 25A0214, 26C0214, 28A0214, 29A0214.
"Guttalax, tablets 5 mg 20 pcs.", Delpharm Reims production, series 150835, 150834.
"Guttalax, tablets 5 mg 50 pcs.", Delpharm Reims production, series 150835A, 150835, 150834, 150836, 150731, 150833.
"Acecardol, enteric-coated tablets 100 mg 10 pcs.", manufactured by Sintez OJSC, series 760714.
"Sodium chloride, a solvent for the preparation of dosage forms for injections 0.9% 10 ml", produced by Grotex LLC, series 931115.
"Hydrogen peroxide, topical solution 3% 100 ml", produced by Iodine Technologies and Marketing LLC, series 2281215.
"Ethyl alcohol, solution for external use and preparation of dosage forms 95% 100 ml", produced by CJSC "RFK", series 010813.

"Doxazosin Zentiva, tablets 2 mg 10 pcs.", manufactured by Zentiva K.S., series 3570815.
"Beloderm, cream for external use 0.05% 15 g", produced by "BELUPO, medicines and cosmetics dd", series 21718104.
"Kromoheksal, solution for inhalation 10 mg / ml 2 ml", manufactured by "Pharma Stulln GmbH / Salutas Pharma GmbH", series 415973, 415976, 415977, 415978, 415980, 425985, 425986, 425987, 425988, 525982. 525020, 525021, 525022, 535027, 535030.
"Acecardol, enteric-coated tablets 100 mg 10 pcs.", manufactured by Sintez OJSC, series 680414, 560414.
"Hydrogen peroxide solution for topical use 3% 100 ml", produced by Iodine Technologies and Marketing LLC, series 210216.
"Acetylsalicylic acid MS, tablets 0.5 g 10 pcs.", produced by CJSC "Medisorb", series 098092014.
"Thyme herb, herb powder 1.5 g, filter bags 20 pcs.", produced by Lek C + LLC, Russia, series 021115.
Bisacodyl-Nizhpharm, rectal suppositories, 10 mg 5 pcs., manufactured by JSC Nizhpharm, Russia, series 60216.
Ketotifen, tablets 1 mg 10 pcs.
"Heparin, solution for intravenous and subcutaneous administration 5000 IU / ml 5 ml", produced by Elfa Laboratories, series NS-30b.
"Cefoperazone and Sulbactam Jodas, powder for solution for intravenous and intramuscular administration 1 g + 1 g", manufactured by Jodas Expoim Pvt. Ltd., series JD584.
"Erespal, syrup 2 mg / ml 150 ml", produced by OJSC "Pharmstandard-Leksredstva", series 140316.

Betaserc 24mg Tablets 20pcs Abbott Healthcare CAC Series 637972.
"Betaserc, 16 mg tablets 15 pcs.", manufactured by Abbott Healthcare CAC, series 638365.
"Nitrazepam, substance-powder", produced by JSC "Organika", series 10212.
"Potassium chloride, solution for injection 1% 200 ml", manufactured by the pharmacy GBU RME "RKB", series An. 411, An. 412.
"Solution of calcium chloride for injection 1% 190 ml", manufacturer of KOGUP "City Pharmacy 206", series An. 541, 545.
"Cerecardp solution for intravenous and intramuscular injection 50 mg/ml 2 ml", manufactured by EcoFarmPlus CJSC, series 530515.
"Sodium thiopental, powder for solution for intravenous administration 1 g, 20 ml bottles", manufactured by Sintez OJSC, series 230515.
"Mexicor, solution for intravenous and intramuscular injection 50 mg / ml 2 ml", manufactured by LLC Firm "FERMENT", series 431015.
"Ketosteril, film-coated tablets 20 pcs.", Produced by "Labesfal Laboratorios Almiro, C.A., Portugal", series 18H3 520.

"Acecardol, enteric-coated tablets 300 mg 10 pcs.", manufactured by Sintez OJSC, series 1351214.
"Paracetamol, tablets 500 mg 10 pcs.", produced by OJSC "Tatkhimfarmpreparaty", series 300216.
"Drotaverine, solution for injection 20 mg / ml 2 ml", produced by CJSC "VIFITECH", series 250614.
"Xylometazoline-SOLOpharm dosed nasal spray 140 mcg / dose 60 doses (10 ml)", manufactured by Grotex LLC, series 100316.
"Hydrogen peroxide solution for topical use 3% 100 ml", produced by Iodine Technologies and Marketing LLC, series 200216, 230216.
"Ammonia, solution for external use and inhalation 10% 40 ml", manufactured by Hippocrat LLC, series 010415, 050515.
"Trichopolum, tablets 250 mg 10 pcs.", Production of the Polpharma Pharmaceutical Plant, series 61111.
"Beloderm, ointment for external use 0.05% 30 g", produced by "BELUPO, medicines and cosmetics dd", series 21434094.
"Iodine, solution for external and local use, alcohol 5% 25 Ml", produced by Iodine Technologies and Marketing LLC, series 301015.

“Flexen, lyophilisate for solution for intramuscular injection 100 mg”, produced by Italfarmaco S.p.A., series 15511/15511.
"Paracetamol, tablets 500 mg 10 pcs.", Production ZLO "PFC Update", series 451215.
"Acyclovir, tablets 400 mg 10 pcs.", produced by Ozon LLC, series 070115, 060115.
"Cefoperazone and Sulbactam Jodas, powder for solution for intravenous and intramuscular administration 1 g + 1 g", manufactured by Jodas Expoim Pvt. Ltd., series 3D546, 3D547, JD563.
"Sodium chloride, a solvent for the preparation of dosage forms for injections 0.9% 10 ml", manufactured by Grotex LLC, series 991115, 1031115.

"Jintropin, lyophilisate for the preparation of a solution for subcutaneous administration", produced by "Genescience Pharmaceuticals Co. Ltd.", series 201304012/r-l 20121202, 201406026/r-l 20121202, 201406032/r-l 20121202, 201407042 Ly 20121202, 20151001/r-l 20141001, 201506028/r-l 20141001, 201506029/r-l 20141001, 20150603/r-l 20141001, 201506 1/r-l 20141001, 201509044/r-l 20141001.
Dikpofenac, rectal suppositories 100 mg 5 pcs., produced by Biochemist OJSC, series 10116, 20116.
"Essentiale forte N, capsules 300 mg 10 pcs.", produced by "A. Nattermann & Sie. GmbH, Series 4K1751.
"Human immunoglobulin normal solution for intravenous administration 50 mg / ml 25 ml", produced by FSUE "NPO "Microgem" of the Ministry of Health of Russia, series H571.
"Chlorhexidine, solution for local and external use 0.05% 100 Ml", produced by JSC NPK "ESKOM", series 320715, 610815.
"Castor oil, oral oil 30 g", produced by CJSC "Yaroslavl Pharmaceutical Factory", series 50815, 61015.

"Sealex Forte", a biologically active food supplement, produced by LLC "VIS".
"Ali Caps", a biologically active food supplement, produced by VIS LLC.
"Glucose-Eskom, solution for intravenous administration 400 mg / ml 10 ml", manufactured by JSC NPK "ESKOM", series 091215.
"Revalgin, solution for injection 5 ml", produced by "Shreya Life Science Pvt. Ltd., series SA 1563003.
"Ranitidine-AKOS, film-coated tablets 150 mg 10 pcs.", manufactured by Sintez OJSC, series 660615.
"Guttalax, tablets 5 mg 20 pcs.", Delpharm Reims production, series 150833.
Validol, sublingual tablets 60 mg 10 pcs.
"Suprastin, solution for intravenous and intramuscular injection 20 mg / ml 1 ml", manufactured by JSC "EGIS Pharmaceutical Plant", series 14A0114.
"Peppermint leaves, leaves powder 1.5 g," production 000 "PKF "Fitopharm", series 030615.

"Ammonia, solution for external use and inhalation 10%" 40 ml, manufactured by Hippocrates LLC, series 010415, 050515, 060515.
"Dermatol", substance-powder 5 kg, produced by FSUE "SKTB "Tekhnolog", series 020415.
"Dysport, lyophilisate for solution for injection 500 IU", K05752 series, labeled on packages and instructions for use medical use in Turkish.
"Hydrogen peroxide, solution for local use 3%" 100 ml, produced by Iodine Technologies and Marketing LLC, series 1030615.
"Sodium chloride, solution 10%" 200 ml, manufacturer pharmacy GBUZ LO "Priozerskaya MB", An series 381, An. 56.

Herceptin, lyophilisate for the preparation of a concentrate for solution for infusion 440 mg, complete with solvent-bacteriostatic water for injection, 20 ml vials, manufactured by Jenentek Inc., CLHA / F. Hoffmann-La Roche Ltd., series 3714/1/ solvent B2096/3.
"Denol", tablets 120 mg 8 pcs., manufactured by Astellas Pharma Europe B.V., series 411082015.
"Folic acid", tablets 1 mg 50 pcs., produced by JSC "Valenta Pharmaceuticals", series 60915.
"Magnesium sulfate solution for external use 5%" 200 ml, manufactured by the pharmacy GBUZ "Penza Regional Clinical Hospital. N.N. Burdenko", marking AN.1.
"Solution of novocaine for external use 5%" 200 ml, manufacturer pharmacy GBUZ "Penza Regional Clinical Hospital. N.N. Burdenko", marking AN.2.

"Paracetamol", tablets 500 mg 10 pcs., produced by ZLO Production Pharmaceutical Company Update (Russia), series 160415.
Abaktal, 400 mg tablets, 10 pcs., produced by Lek dd, ED9747 series.
"Lizinopril" tablets 5 mg 30 pcs., produced by Ozon LLC, series 141214.
"Calcium chloride solution 1%" 200 ml P.P. Zhemchuev”, series 157/162.
"Solution of novocaine 1%" 200 ml P.P. Zhemchuev”, series 158/163.
"Solution of novocaine 2%" 200 ml P.P. Zhemchuev”, series 159/164.
"Ammonia, solution for external use and inhalation 10%" 40 ml, manufactured by Hippocrates LLC, series 010415.
"Eucalyptus tincture", tincture 25 ml, produced by ZLO "Yaroslavl Pharmaceutical Factory", series 10715.

We constantly monitor the discovery of problems in food products (as, for example, in the case of the "black list" of dairy producers) and write about recall campaigns for products used by many consumers: smartphones, laptops, tablets, strollers and strollers for newborns. as well as many others.

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