FDA Drug recall D-0129-2024
PAROXETINE tablets, USP, 20 mg, Packaged as a) 90-count bottle NDC 60429-735-90
- FDA Drug
- Class II
- terminated
- Published 2023-12-06
On 2023-12-06 the FDA classified a Class II recall of PAROXETINE tablets, USP, 20 mg, Packaged as a) 90-count bottle NDC 60429-735-90 by Golden State Medical Supply, citing failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0129-2024 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-11-10 |
| Published | 2023-12-06 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Golden State Medical Supply |
| Distribution | US |
Product
PAROXETINE tablets, USP, 20 mg, Packaged as a) 90-count bottle NDC 60429-735-90; b)1000-count bottle, NDC 60429-735-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorporated, Camarillo, CA 93012.
Reason
Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
Identifiers
| ndc | 60429-734-30 |
|---|---|
| ndc | 60429-734-90 |
| ndc | 60429-734-10 |
| ndc | 60429-735-30 |
| ndc | 60429-735-90 |
| ndc | 60429-735-10 |
| ndc | 60429-736-30 |
| ndc | 60429-736-90 |
| ndc | 60429-736-10 |
| ndc | 60429-737-30 |
| ndc | 60429-737-90 |
| ndc | 60429-737-10 |
| code_info | Lot # a) GS036696, GS037068, GS037934, GS038564, Exp. 08/31/2024 b) GS036381, GS036712, GS037116, GS037692, GS038388, Exp. 08/31/2024; |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0129-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.