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Public Alert No: 0038/2018 – Alert on All Lots of Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets By Teva Pharmaceuticals, USA.

The National Agency for Food and Drug Administration and Control has been informed that Teva Pharmaceuticals, USA is voluntarily recalling all lots of Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets due to an impurity detected in Valsartan, one of the active pharmaceutical ingredient (API) in the combinations. Mylan Laboratories Limited, Hyderabad, India manufactured Valsartan that contains the impurity known as N-nitroso-diethylamine (NDEA), which has been classified as a probable human carcinogen.

Amlodipine/Valsartan combination tablets and Amlodipine/Valsartan/Hydrochlorothiazide combination tablets are used for the treatment of high blood pressure.

Patients taking Amlodipine / Valsartan combination tablets or Amlodipine / Valsartan / Hydrochlorothiazide combination tablets should contact their doctor or pharmacist for advice as stopping the drugs immediately with no comparable alternative could pose a greater risk to patients’ health.

Amlodipine/Valsartan combination tablets and Amlodipine/Valsartan/Hydrochlorothiazide combination tablets manufactured by Teva Pharmaceuticals, USA are not registered by the Agency.

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

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

Healthcare providers and other members of the public are advised to stop the administration of the affected products that might have been bought privately from the United States of America 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!!!