Mylan Expands Recall to All Unexpired Lots of Valsartan in US

Mylan Pharmaceuticals is expanding its voluntary recall to include all lots of nonexpired valsartan-containing products because of the presence of trace amounts of the probable carcinogen N-nitrosodiethylamine (NDEA) in the valsartan active pharmaceutical ingredient (API) manufactured by the company.

On November 20, as reported by Medscape Medical News, Mylan recalled 15 lots of medicines containing valsartan because of NDEA contamination. This recall included six lots of amlodipine/valsartan tablets, seven lots of valsartan tablets, and two lots of valsartan and hydrochlorothiazide tablets.

The 104 additional lots include 26 lots of amlodipine/valsartan tablets, 51 lots of valsartan tablets, and 27 lots of valsartan and hydrochlorothiazide tablets. 

These lots, like the others, were distributed in the United States between March 2017 and November 2018, according to the December 4 recall notice posted on the US Food and Drug Administration (FDA) website.

Mylan is notifying its distributors and customers of the recall by letter and is arranging for return of all recalled products. Wholesalers, retailers, and consumers with recalled product should contact Stericycle between 8 AM and 5 PM EST at 1-888-406-9305 to return the product.

On November 27, Teva Pharmaceuticals recalled all lots of amlodipine/valsartan combination tablets and amlodipine/valsartan/hydrochlorothiazide combination tablets in the United States after NDEA was detected in the API manufactured by Mylan India.

The European Medicines Agency (EMA) recently banned sales of valsartan made by Mylan Laboratories of Hyderabad after some batches were found to contain NDEA.

The FDA and EMA are continuing to investigate the presence of NDEA and another probable carcinogen, N-nitrosodimethylamine (NDMA), in angiotensin II receptor blockers.

The agency is keeping an updated list of valsartan products under recall and a list of valsartan products not under recall.

For more information, please visit: FDA updates on angiotensin II receptor blocker (ARB) recalls.

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