Roszdravnadzor detected and recalled 2 counterfeit drugs in H1

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The Federal Service for Surveillance in Healthcare released the results of state control (surveillance) over the circulation of medicinal products for H1 2017.

According to this information, in H1 2017, the agency recalled 367 batches of medicinal products, the quality of which failed to meet the established requirements.

The share of batches with poor-quality medicines manufactured in Russia was 56.1% (84 trade names in 142 batches), while the share of foreign-made products was 43.9% (45 trade names in 111 batches).

Overall, as of July 01, 2017, the agency detected and recalled 2 batches of 2 trade names of counterfeit drugs:

No.

Trade name of medicinal product

Manufacturer, country (according to accompanying documents)

Batch number

Reporter

Number and date of the letter of Roszdravnadzor on recall of medicinal product

1 Streptokinase, lyophilisate for the solution for intravenous and intraarterial administration 1500000 IU, vial (1), carton RUP Medpreparaty, Republic of Belarus 011115 Omela LLC No. 01И – 1003/17 of 24.04.201
2 Exoderil, solution for external use 1%, 10 ml, dark-glass vial (1), carton Sandoz GmbH, Biochemiestrasse, 10, A-6250, Kundl, Austria

Manufactured by: Globopharm Рharmazeutische Productions und Handels, GmbH, Austria

146381 ZAO Sandoz No. 01И – 1257/17 of 31.05.2017
SOURCE: gmpnews.ru
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