Recalls / Class II
Class IID-0271-2019
Product
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.
- Affected lot / code info
- 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
Why it was recalled
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Recalling firm
- Firm
- Sciegen Pharmaceuticals Inc
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 89 Arkay Dr, N/A, Hauppauge, New York 11788-3727
Distribution
- Quantity
- 18,760 HDPE bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2018-10-29
- FDA classified
- 2018-11-20
- Posted by FDA
- 2018-11-28
- Terminated
- 2023-09-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0271-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.