To be Withdrawn from Circulation
Federal Service For Surveillance in Healthcare has published information on withdrawal of falsified drug EssentialeÒ Forte N, Capsules 300 mg 10 pcs, blister packages (3), carton packs batch 4К1751, with packages specifying A. Natermann und Sie. GmbH, Germany”. The decision was made on the basis of information provided by the Federal State Budgetary Institution Information and Methodical Center of Expertise, Accounting and Analysis of Circulation of Drugs”under Roszdravnadzor (Gudermes affiliate).
Packs of the above batch of the drug with distinctive features of falsification in description, on blister packaging, package insert, blister label, carton pack, are subject to withdrawal and destruction.
Besides, Roszdravnadzor also suspended the certificate of suitability for the pharmaceutical substance of Simvastatin. The decision was based on the information received by the Federal Service for Surveillance in Healthcare from the European Directorate on Quality of Medical Products and on suspension of certificate of suitability for Simvastatin by Artemis Biotec (a company of Temis Medicare Limited), India, based on results of inspection of the production site.
From July 25 to August 8, 2016 Roszdravnadzor recalled the following drugs from circulation:
— ”Ammonia, solution for oral use and for inhalations 10% 40 mL, dark glass vials”, batch 020415 and batch 030415 by Hippocrates LLC, Russia (cause: non-compliance with regulatory documentation for “Description”);
— “Thyme herb, powder 1.5 g, sachets 20 pcs., carton pack”, batches 021115 by Lek S+ LLC, Russia (non-compliance with regulatory documentation for Microbiological Purity);
“Alpha tocopharol acetate, oily solution (vitamin E), oily solution for oral use 10% 20 mL dark glass vial, batch 050416 Samaramedprom JSC, Russia (non-compliance with regulatory documentation for “Description”) ;
“ChondroxideÒ Maximum, cream for external use 8% 50 g, tubes (1), carton packs”, batches А419НМ, А420НМ by Licht Far East (S) Pty Ltd, Singapore (non-compliance with regulatory documentation for “Assay of dimethyl sulfoxide”);
“Diazolin pellets 50 mg, 10 pcs, blister package (1), carton packs, batch 081215 by JSC Pharmstandard UfaVITA, Russia (non-compliance with regulatory documentation for “Labeling”);
“Glucose, solution for intravenous administration, 400 mg/mL 10 ml ampoules (10), carton packs, batches 080215, 090215, 100315 by Grotex LLC, Russia (non-compliance with regulatory documentation for “pH”).