FDA Drug recall D-0128-2024
PAROXETINE tablets, USP, 10 mg, Packaged as a) 30-count bottle, NDC 60429-734-30
- FDA Drug
- Class II
- terminated
- Published 2023-12-06
On 2023-12-06 the FDA classified a Class II recall of PAROXETINE tablets, USP, 10 mg, Packaged as a) 30-count bottle, NDC 60429-734-30 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-0128-2024 |
| 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, 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
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) Lot GS041383, GS042141, Exp. 08/31/2024; b) Lot GS040841, Lot GS041384, Lot GS042039, Exp. 08/31/2024; c) Lot…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; |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Other recalls by Golden State Medical Supply
- Prasugrel HCI, Tablets, USP, 10mg, 30-count bottle, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC: 51407-445-30
FDA Drug · Class II · 2026-09-09 · Golden State Medical Supply - Carbamazepine Tablets, USP, 200mg, packaged in a)1000-count bottles (NDC 51407-215-10), b) 100-count bottles (NDC 51407-215-01), Rx Only, M…
FDA Drug · Class II · 2026-08-26 · Golden State Medical Supply - GSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets, Rx only, Manufactured by Kremers Urban Pharmaceuticals Inc.,…
FDA Drug · Class II · 2026-06-17 · Golden State Medical Supply - Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo…
FDA Drug · Class III · 2026-05-27 · Golden State Medical Supply - Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camaril…
FDA Drug · Class III · 2026-05-27 · Golden State Medical Supply
All Golden State Medical Supply recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0128-2024%22
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