Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP 75 Mg, 150 Mg, and 300 Mg
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 below.
Details of batches sent to Westminster
The Irbesartan tablets subject to recall are packed in 30-count and 90-count bottles. To help identify the recalled product, the NDCs, product description, lot numbers and expiration dates are listed below. These lots were distributed nationwide in the USA to Westminster’s direct accounts.
Westminster is notifying its direct accounts by email and by phone to immediately discontinue distribution of the product being recalled and to notify their wholesale and retail accounts of this product recall and make arrangements for impacted product to be returned to Westminster. Instructions for returning recalled products are provided in the Recall Notice Letter and Recall Response Form. Patients should return the effected medication to their pharmacy. Pharmacies should return their effected stock to their wholesaler.
If you are taking Irbesartan, please examine your tablets and look for the specific markings to determine if you’re product is affected by this recall. Products can be best identified by patients as being white, oval shaped tablets debossed with SG 160; SG 161; or SG 162.
Customers and patients with medical-related questions, information about an adverse event or other questions about the Westminster’s product’s being recalled should contact Westminster’s Regulatory Affairs department by phone at: 888-354-9939
- Live calls are received Monday-Friday, 9:00AM - 5:00PM EST with voicemail available 24 hours/day, 7 days/week or email firstname.lastname@example.org.
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