Following the ban of Valsartan, the Nigerian Government has sent a strong warning to drug marketers informing them to desist from the importation, distribution and sale of the drug.
Valsartan is a drug used to control blood pressure and to prevent heart failure which has now been recalled due to possible contamination with N-nitrosodimethylamine (NDMA) which has genotoxic and carcinogenic potentials.
The National Agency for Food and Drug Administration and Control (NAFDAC) gave the warning in a statement on its official website earlier this week.
Medicines and Healthcare Products Regulatory Agency (MHRA) informed NAFDAC 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 contamination is as a result of change in the manufacturing process of the active substance (valsartan) manufactured in China.
It will be recalled that the United States Food and Drug Administration (FDA) last month updated its blood pressure drug recall list to warn consumers of the voluntary valsartan blood pressure medication callback.
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 advised anybody in possession of these products to submit them to the nearest NAFDAC office and stop administration in order to safeguard the lives of Nigerians.