ARIPIPRAZOLE Recall D-1285-2022
Description: Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2676-8, UPC 3 60505 26768 2), b) 30-count bottle (NDC 60505-2676-3, UPC 3 60505 26763 7), Rx only, Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326
ARIPIPRAZOLE Recall D-1285-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1285-2022 |
| Event ID | 90569 |
| Brand | ARIPIPRAZOLE |
| Generic Name | ARIPIPRAZOLE |
| Manufacturer | ARIPIPRAZOLE |
| Original Package? | 1 |
| Active Substance | ARIPIPRAZOLE |
| Drug Route | ORAL |
| Distribution | USA Nationwide |
| Quantity | 2010 bottles |
| Recall Reason | Failed dissolution specifications: OOS for dissolution at the 12-month stability time point. |
| Drug Classification | Class II |
| Drug Code Info | 20220727 |
| Product NDC | 60505-2673 60505-3075 60505-2674 |
| Product NUI | N0000175430 |
| Drug UPC | 360505267682 360505267637 |
| Pharma Class (EPC) | Atypical Antipsychotic [EPC] |
| Recall Initiation Date | 20220707 |
| Report Date | 20220727 |
| Classification Date | 20220721 |
| Address | 2400 N Commerce Pkwy Ste 400 Weston, FL 33326-3253 United States |
| Recalling Firm | Apotex Corp. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 82VFR53I78 |
| Drug Application Number | ANDA078583 |
| Structured Product Labeling (SPL ID) | 40ac4f7e-0729-b1f9-3951-e5bc26008e2e |
| Structured Product Labeling (SPL Set ID) | 569f1c32-fb6f-c34f-0894-4b1e7b744a8a |
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