PAROXETINE HYDROCHLORIDE ANHYDROUS Recall D-0119-2024
Description: Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: 60505-0097-1; b) 100-count bottle, NDC#: 60505-0097-2; c) 1000-count bottle, NDC#: 60505-0097-4, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.
PAROXETINE HYDROCHLORIDE ANHYDROUS Recall D-0119-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0119-2024 |
| Event ID | 93353 |
| Brand | PAROXETINE |
| Generic Name | PAROXETINE HYDROCHLORIDE |
| Manufacturer | PAROXETINE HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | PAROXETINE HYDROCHLORIDE ANHYDROUS |
| Drug Route | ORAL |
| Distribution | Nationwide |
| Quantity | 34,392 |
| Recall Reason | Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine |
| Drug Classification | Class II |
| Drug Code Info | 20231206 |
| Product NDC | 60505-0083 60505-0097 60505-0084 |
| Drug UPC | 0360505008414 0360505009718 0360505008315 |
| Recall Initiation Date | 20231101 |
| Report Date | 20231206 |
| Classification Date | 20231127 |
| Address | 2400 N Commerce Pkwy Ste 400 Weston, FL 33326-3253 United States |
| Recalling Firm | Apotex Corp. |
| Initial Notification | |
| Unique Ingredient Identifier | 3I3T11UD2S |
| Drug Application Number | ANDA075356 |
| Structured Product Labeling (SPL ID) | 17c7bfb9-ae58-35df-6bb4-8fe62c6302a5 |
| Structured Product Labeling (SPL Set ID) | 08320ea3-8f93-6f04-5d1c-f69af3eb5a81 |
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