Recalls / Class II
Class IID-0263-2019
Product
IRBESARTAN Tablets, USP 75 mg 90-count bottle, Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC 60429-640-90.
- Affected lot / code info
- Lot Numbers: B160003; Exp. 09/19 B160004; Exp. 09/19
Why it was recalled
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product.
Recalling firm
- Firm
- Golden State Medical Supply Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5187 Camino Ruiz, N/A, Camarillo, California 93012-8601
Distribution
- Quantity
- 2,439 bottles
- Distribution pattern
- Product was distributed throughout the United States.
Timeline
- Recall initiated
- 2018-11-02
- FDA classified
- 2018-11-20
- Posted by FDA
- 2018-11-28
- Terminated
- 2020-09-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0263-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.