ARIPIPRAZOLE Recall D-0368-2023
Description: Aripiprazole Tablets, USP 15 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-281-10, UPC 3 16729 28110 2; b) 100-count bottle NDC 16729-281-01, UPC 3 16729 28101 0; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India
ARIPIPRAZOLE Recall D-0368-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0368-2023 |
| Event ID | 91657 |
| Brand | ARIPIPRAZOLE |
| Generic Name | ARIPIPRAZOLE |
| Manufacturer | ARIPIPRAZOLE |
| Original Package? | 1 |
| Active Substance | ARIPIPRAZOLE |
| Drug Route | ORAL |
| Distribution | United States including Puerto Rico and Canada |
| Quantity | 312,864 bottles |
| Recall Reason | CGMP Deviations: recalling drug products following an FDA inspection. |
| Drug Classification | Class II |
| Drug Code Info | 20230308 |
| Product NDC | 16729-278 16729-279 16729-280 |
| Product NUI | N0000175430 |
| Drug UPC | 316729281102 316729281010 |
| Pharma Class (EPC) | Atypical Antipsychotic [EPC] |
| Recall Initiation Date | 20230207 |
| Report Date | 20230308 |
| Classification Date | 20230302 |
| Address | 1009 Slater Rd Ste 210B Durham, NC 27703-8446 United States |
| Recalling Firm | Accord Healthcare, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 82VFR53I78 |
| Drug Application Number | ANDA206251 |
| Structured Product Labeling (SPL ID) | ed7d1a33-7a1d-8ab1-e053-2a95a90a6813 |
| Structured Product Labeling (SPL Set ID) | 85cc7d25-414b-4b6f-a03a-48af908a16a1 |
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