Home / Recalls / Golden State Medical Supply Inc. / D-0264-2019

D-0264-2019 Class II Terminated

Recalled by Golden State Medical Supply Inc. — Camarillo, CA

Recall Details

Product Type
Drugs
Report Date
November 28, 2018
Initiation Date
November 2, 2018
Termination Date
September 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

Other recalls by Golden State Medical Supply Inc.

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  • D-0287-2025 Class II — PRASUGREL TABLETS, 5 mg, 30 tablet bottles, Rx only, packaged by GSMS, Incorpora (March 5, 2025)
  • D-0568-2024 Class II — Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, (May 13, 2024)
  • D-0349-2024 Class II — Fluticasone Propionate Nasal Spray USP, 50 mcg per spray, 120 metered sprays, 16 (February 14, 2024)
  • D-0276-2024 Class II — Budesonide Extended-Release Tablets, 9 mg, 30-count bottles, Rx only, Marketed b (January 12, 2024)
  • D-0130-2024 Class II — PAROXETINE tablets, USP, 40 mg, Packaged as a) 30-count bottle, NDC 60429-737-3 (November 10, 2023)
  • D-0129-2024 Class II — PAROXETINE tablets, USP, 20 mg, Packaged as a) 90-count bottle NDC 60429-735-90; (November 10, 2023)
  • D-0128-2024 Class II — PAROXETINE tablets, USP, 10 mg, Packaged as a) 30-count bottle, NDC 60429-734-3 (November 10, 2023)
  • D-0867-2023 Class II — Travoprost Ophthalmic Solution, USP (Ionic Buffered Solution), 0.004%, Rx only, (May 25, 2023)