GSMS Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 60429-641-30), (b) 90-count bottle (NDC 60429-641-90), Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 60429-641-90 Irbesartan 150mg Tablets, 90 Count Bottle B161003 Sep-19 B161004 Sep-19 B161006 Sep-19 B161007 Sep-19 B161008 Nov-19 B161009 Nov-19 B161010 Nov-19 C161001 Feb-20 C161003 May-20 60429-641-30 Irbesartan 150mg Tablets, 30 Count Bottle GS019526 Nov-19 GS020252 Nov-19 GS020958 Nov-19
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Sciegen Pharmaceuticals Inc
- Reason for Recall:
- CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
GSMS Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 60429-641-30), (b) 90-count bottle (NDC 60429-641-90), Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA.
Product Codes/Lot Numbers:
60429-641-90 Irbesartan 150mg Tablets, 90 Count Bottle B161003 Sep-19 B161004 Sep-19 B161006 Sep-19 B161007 Sep-19 B161008 Nov-19 B161009 Nov-19 B161010 Nov-19 C161001 Feb-20 C161003 May-20 60429-641-30 Irbesartan 150mg Tablets, 30 Count Bottle GS019526 Nov-19 GS020252 Nov-19 GS020958 Nov-19
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0271-2019
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CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.