Class II
Terminated
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.
- Company
- Golden State Medical Supply Inc.
- Recall Initiated
- November 2, 2018
- Posted
- November 28, 2018
- Recall Number
- D-0263-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2,439 bottles
- Firm Location
- Camarillo, CA, United States
Reason for Recall
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product.
Distribution
Product was distributed throughout the United States.
Lot / Code Info
Lot Numbers: B160003; Exp. 09/19 B160004; Exp. 09/19
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