Golden State Medical Supply Inc.: Drug Recall

Recall #D-0128-2024 · 11/10/2023

Class II: Risk

Recall Details

Recall Number
D-0128-2024
Classification
Class II
Product Type
Drug
Recalling Firm
Golden State Medical Supply Inc.
Status
Terminated
Date Initiated
11/10/2023
Location
Camarillo, CA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1941 bottles

Reason for Recall

Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine

Product Description

PAROXETINE tablets, USP, 10 mg, Packaged as a) 30-count bottle, NDC 60429-734-30; b) 90-count bottle NDC 60429-734-90; c)1000-count bottle, NDC 60429-734-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorporated, Camarillo, CA 93012.

Distribution Pattern

Nationwide in the USA

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.