FDA Drug recall D-0106-2021
Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, NDC 60505-2675-8
- FDA Drug
- Class II
- terminated
- Published 2020-11-25
On 2020-11-25 the FDA classified a Class II recall of Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, NDC 60505-2675-8 by Apotex, citing failed Dissolution Specifications: Out of specification for dissolution.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0106-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-11-11 |
| Published | 2020-11-25 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Apotex |
| Distribution | US |
Product
Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, NDC 60505-2675-8; b) 30 count bottle, NDC 60505-2675-3; Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326
Reason
Failed Dissolution Specifications: Out of specification for dissolution.
Identifiers
| code_info | a) PZ6716 Exp. 02/2021; b) PZ6715 Exp. 02/2021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0106-2021%22
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