ScieGen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)
Company Contact:
Siva Reddy P.V
Toll free Number: (1)-855-724-3436

10/29/2018 – ScieGen Pharmaceuticals, Inc. is voluntarily recalling listed lots, within expiry, of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms to the consumer level. “These products are being recalled due to the presence of an impurity,
N-nitrosodiethylamine (NDEA) contained in the API Irbesartan, USP manufactured by Aurobindo Pharma Limited”
. This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a “probable human carcinogen as per International Agency for Research on Cancer (IARC)”
To date, Sciegen Pharmaceuticals Inc has not received any reports of adverse events related to this product.
Irbesartan tablets, USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg were manufactured by ScieGen Pharmaceuticals Inc and are labeled as Westminster Pharmaceuticals and Golden State Medical Supply, Inc [GSMS].
The recalls and returns will be managed by the respective distributors separately for the lots distributed by them as outlined in the letter below.

Sciegen Irbesartan Recall notice dated Oct 29

ScieGen Pharmaceuticals Recall FAQ