Multi event Drug Recall Enforcement Report Class II voluntary initiated by Golden State Medical Supply Inc., originally initiated on 11-10-2023 for the 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. The product was recalled due to failed impurities/degradation specifications-manufacturer apotex inc. recalling lots due to out of specification results for the excipient amadori glucose adduct of paroxetine. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
D-0129-2024 | 11-10-2023 | 12-06-2023 | Class II | 2502 bottles | 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. | Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine | Ongoing |
D-0130-2024 | 11-10-2023 | 12-06-2023 | Class II | 5626 bottles | PAROXETINE tablets, USP, 40 mg, Packaged as a) 30-count bottle, NDC 60429-737-30; b) 90-count bottle NDC 60429-737-90; c)1000-count bottle, NDC 60429-737-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorporated, Camarillo, CA 93012. | Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine | Ongoing |
D-0128-2024 | 11-10-2023 | 12-06-2023 | Class II | 1941 bottles | 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. | Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine | Ongoing |
Recalled Products