Alembic underscores safety of valsartan products

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Alembic underscores safety of valsartan products

By Sandra Levy - 08/07/2018
Alembic Pharmaceuticals is informing patients, doctors and pharmacists that its valsartan-containing products (valsartan, valsartan and hydrochlorothiazide, amlodipine and valsartan) are not subject to the recent Food and Drug Administration recall.

"Alembic’s valsartan and the active pharmaceutical ingredient are produced internally at Alembic and not outsourced,” the company said in a press statement. "All products are inspected and tested to ensure the highest quality before entering the U.S. market. At Alembic, our top priority is to deliver quality healthcare solutions and ensure patient safety," the company said.

On July 13, the FDA announced a voluntary recall of several drug products containing the active ingredient valsartan used to treat high blood pressure and heart failure. The recall is due to an impurity, N-nitrosodimethylamine, or NDMA, which was found in the recalled products. Not all products containing valsartan are being recalled. NDMA is classified as a probable human carcinogen — a substance that could cause cancer — based on results from laboratory tests. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured, according to the FDA.

Alembic provided the NDC’s and product descriptions of its products that contain valsartan:

  • 62332-0044 valsartan tablets, 40 mg

  • 62332-0045 valsartan tablets, 80 mg

  • 62332-0046 valsartan tablets, 160 mg

  • 62332-0047 valsartan tablets, 320 mg

  • 62332-0079 valsartan and hydrochlorothiazide tablets, 80 / 12.5 mg

  • 62332-0080 valsartanand hydrochlorothiazide tablets, 160 / 12.5 mg

  • 62332-0081 valsartanand hydrochlorothiazide tablets, 160 / 25 mg

  • 62332-0082 valsartanand hydrochlorothiazide tablets, 320 / 12.5 mg

  • 62332-0083 valsartan and hydrochlorothiazide tablets, 320 / 25 mg

  • 62332-0205 amlodipine and valsartan tablets, 5 / 160 mg

  • 62332-0206 amlodipine and valsartan tablets, 10 / 160 mg

  • 62332-0207 amlodipine and valsartan tablets, 5 / 320 mg

  • 62332-0208 amlodipine and valsartan tablets, 10 / 320 mg

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