D-0128-2024 Class II Terminated
FDA drug recall D-0128-2024 was initiated by Golden State Medical Supply Inc. on Nov 10, 2023 and is designated Class II. 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 The recall status is terminated (terminated Mar 21, 2025). Affected quantity: 1941 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Dec 6, 2023
- Initiation Date
- Nov 10, 2023
- Termination Date
- Mar 21, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1941 bottles
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.
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
Distribution pattern
Nationwide in the USA
Code information
Lot # a) Lot GS041383, GS042141, Exp. 08/31/2024; b) Lot GS040841, Lot GS041384, Lot GS042039, Exp. 08/31/2024; c) Lot GS040910, Lot GS041621, Lot GS042237, Exp. 08/31/2024;
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0128-2024
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026