The National Agency for Food and Drug Administration and Control on the 10th of July 2018, announced a recall of Valsartan, the anti-hypertensive drug in the Angiotensin receptor blocker class. This was following notification from the UK medicines regulator, MHRA, of the potential contamination of Valsartan tablets manufactured by Accord Healthcare previously known as Actavis Group PTC EHF.
The recall affects all batches and are being recalled from pharmacies as a precautionary measure in Europe. NAFDAC has issued a similar recall notice in Nigeria. Their press release indicates that:
‘all importers, wholesalers and retailers are 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’.
The recall is reportedly 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.
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|
See the notice on NAFDAC’s website
We’ve written in the past about the importance of being able to carry out drug recalls and we’re delighted that users of WellaHealth’s engage software can interrogate their records to find which patients this recall affects and inform them accordingly. Call us on 08179045442 or chat with us online to learn how to do it. Not signed up. Visit our website and input your number to learn how it works.