D-0264-2019 Class II Terminated
FDA drug recall D-0264-2019 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: 15,917 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
- 15,917 bottles
Product Description
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: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA.
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: 30-count bottles: GS019526; Exp. 11/19 GS020252; Exp. 11/19 GS020958; Exp. 11/19 Lot Numbers: 90-count bottles B161003; Exp. 09/19 B161004; Exp. 09/19 B161006; Exp. 09/19 B161007; Exp. 09/19 B161008; Exp. 11/19 B161009; Exp. 11/19 B161010; Exp. 11/19 C161001; Exp. 02/20 C161003; Exp. 05/20
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0264-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026