PAROXETINE HYDROCHLORIDE ANHYDROUS Recall D-0128-2024
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.
PAROXETINE HYDROCHLORIDE ANHYDROUS Recall D-0128-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0128-2024 |
| Event ID | 93431 |
| Brand | PAROXETINE |
| Generic Name | PAROXETINE HYDROCHLORIDE |
| Manufacturer | PAROXETINE HYDROCHLORIDE |
| Active Substance | PAROXETINE HYDROCHLORIDE ANHYDROUS |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA |
| Quantity | 1941 bottles |
| Recall Reason | Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine |
| Drug Classification | Class II |
| Drug Code Info | 20231206 |
| Product NDC | 60429-734 60429-735 60429-736 |
| Recall Initiation Date | 20231110 |
| Report Date | 20231206 |
| Classification Date | 20231130 |
| Address | 5187 Camino Ruiz Camarillo, CA 93012-8601 United States |
| Recalling Firm | Golden State Medical Supply Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 3I3T11UD2S |
| Drug Application Number | ANDA075356 |
| Structured Product Labeling (SPL ID) | 091f4195-a70a-ae35-e063-6294a90a3e89 |
| Structured Product Labeling (SPL Set ID) | e63fe922-b35a-406c-8737-f3f5e6d5a30d |
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