Recalls / Class II
Class IID-0272-2019
Product
GSMS Irbesartan Tablets, USP, 300 mg,(a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90), Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA.
- Affected lot / code info
- 60429-642-30 Irbesartan 300mg Tablets, 30 Count Bottle GS019036 Sep-19 GS019073 Sep-19 GS021472 Nov-19 GS021530 Nov-19 GS022234 Feb-20 60429-642-90 Irbesartan 300mg Tablets, 90 Count Bottle B162009 Sep-19 B162010 Sep-19 B162011 Sep-19 B162012 Nov-19 B162013 Nov-19 B162014 Nov-19 B162015 Nov-19 C162001 Feb-20
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
- 30,194 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-0272-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.