D-0263-2019 Class II Terminated
FDA drug recall D-0263-2019 was initiated by Golden State Medical Supply Inc. on Nov 2, 2018 and is designated Class II. Reason for recall: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product. The recall status is terminated (terminated Sep 16, 2020). Affected quantity: 2,439 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Nov 28, 2018
- Initiation Date
- Nov 2, 2018
- Termination Date
- Sep 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,439 bottles
Product description
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.
Reason for recall
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product.
Distribution pattern
Product was distributed throughout the United States.
Code information
Lot Numbers: B160003; Exp. 09/19 B160004; Exp. 09/19
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0263-2019
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026