Alembic: Valsartan Products Not Subject to Recall

JULY 31, 2018
Officials with Alembic Pharmaceuticals, Inc. have issued a statement to patients, doctors, and pharmacists that Alembic’s Valsartan containing products (Valsartan, Valsartan & Hydrochlorothiazide, Amlodipine & Valsartan) are not subject to the recent FDA recall.

Earlier in the month, FDA officials announced that several, but not all, drug products containing the active ingredient valsartan, were recalled due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. NDMA is classified as a probable human carcinogen based on results from laboratory tests.

Alembic’s Valsartan and the Active Pharmaceutical Ingredient (“API”) are produced internally at Alembic and not outsourced, according to a statement from the company that was provided to Pharmacy Times. "All products are inspected and tested to ensure the highest quality before entering the US market," the statement noted.

The following are the NDC’s and product descriptions of products provided by Alembic Pharmaceuticals containing Valsartan:

NDC Description
  • 62332-0044 Valsartan Tablets USP 40 mg
  • 62332-0045 Valsartan Tablets USP 80 mg
  • 62332-0046 Valsartan Tablets USP 160 mg
  • 62332-0047 Valsartan Tablets USP 320 mg
  • 62332-0079 Valsartan & Hydrochlorothiazide Tablets USP 80 / 12.5 mg
  • 62332-0080 Valsartan & Hydrochlorothiazide Tablets USP 160 / 12.5 mg
  • 62332-0081 Valsartan & Hydrochlorothiazide Tablets USP 160 / 25 mg
  • 62332-0082 Valsartan & Hydrochlorothiazide Tablets USP 320 / 12.5 mg
  • 62332-0083 Valsartan & Hydrochlorothiazide Tablets USP 320 / 25 mg
  • 62332-0205 Amlodipine & Valsartan Tablets USP 5/160 mg
  • 62332-0206 Amlodipine & Valsartan Tablets USP 10/160 mg
  • 62332-0207 Amlodipine & Valsartan Tablets USP 5/320 mg
  • 62332-0208 Amlodipine & Valsartan Tablets USP 10/320 mg

If patients have any questions about the product they have been taking, they are urged to contact a pharmacist or health care provider.
 
Read about the additional impurity found in some recalled products containing valsartan.


 

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