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Recall Of Valsartan Due To Contamination

 

August 2, 2018,

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 European level.

The recall is due to possible contamination of the active pharmaceutical ingredient (API – Valsartan) supplied by Zhejiang Huahai in China. N-nitrosodimethylamine (NDMA), the contaminant has genotoxic and carcinogenic potentials.

The details of the affected products are:

Product Name Marketing Authorization Holder Product License
Valsartan 40mg capsules, hard DexcelPharm 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

It should be noted that the alert is not for all products containing Valsartan. It is for manufactured products listed above that contain Valsartan API supplied by Zhejiang Huahai.

Valsartan capsules manufactured by Dexcel Pharma Ltd and Valsartan tablets manufactured by Accord Healthcare previously known as Actavis Group PTC EHF were not registered with the Agency.

Therefore, there is no recall or request by NAFDAC for manufacturers to remove the products from the Nigerian market.

NAFDAC implores all importers, wholesalers and retailers to not illegally import distribute and sell any of the affected products.

Healthcare providers and other members of the public are also advised to stop the administration of the affected products that might have been bought privately from the United Kingdom or other countries for private use. Anybody in possession of the affected products should submit them 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 pharmacovigilance@nafdac.gov.ng

NAFDAC…………….Safeguarding the health of the nation!!!