Recall Of Valsartan Due To Contamination
The National Agency for Food and Drug Administration and Control has been notified by Medicines and Healthcare Products Regulatory Agency (MHRA) that all batches of Valsartan capsules manufactured by Dexcel Pharma Ltd and all batches of Valsartan tablets manufactured by Accord Healthcare previously known as Actavis Group PTC EHF are being recalled from pharmacies as a precautionary measure at a European level. The recall is due to possible contamination with N-nitrosodimethylamine (NDMA) which has genotoxic and carcinogenic potentials. The contamination is as a result of change in the manufacturing process of the active substance (valsartan) manufactured in China.
Valsartan is a drug used to control blood pressure and to prevent heart failure.
The details of the affected products are as follows:
|Product Name||Marketing Authorization Holder||Product License|
|Valsartan 40mg capsules, hard||Dexcel Pharm Limited||PL 14017/0192|
|Valsartan 80mg capsules, hard||Dexcel Pharm Limited||PL 14017/0193|
|Valsartan 160mg capsules, hard||Dexcel Pharm Limited||PL 14017/0194|
|Valsartan 40mg film-coated tablets||Actavis Group PTC EHF||PL 30306/0109|
|Valsartan 80mg film-coated tablets||Actavis Group PTC EHF||PL 30306/0110|
|Valsartan 160mg film-coated tablets||Actavis Group PTC EHF||PL 30306/0111|
|Valsartan 320mg film-coated tablets||Actavis Group PTC EHF||PL 30306/0405|
NAFDAC implores all importers, wholesalers and retailers to immediately stop the importation, distribution and sale of these products. Anybody in possession of these products are to submit them to the nearest NAFDAC office.
Healthcare providers should stop the administration of these products to patients and submit any quantity in their possession to the nearest NAFDAC office.
Consumers are advised to report adverse events related to the use on any of these products to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks) or via email@example.com.
NAFDAC………….Safeguarding the health of the nation!!!