FDA Drug recall D-0692-2017
Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada, Distributed by Major Ph…
- FDA Drug
- Class III
- terminated
- Published 2017-05-10
On 2017-05-10 the FDA classified a Class III recall of Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada, Distributed by Major Ph… by The Harvard Drug Group, citing superpotent Drug; out of specification results for assay (manufacturer).
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0692-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-12-27 |
| Published | 2017-05-10 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | The Harvard Drug Group |
| Distribution | US |
Product
Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada, Distributed by Major Pharmaceuticals, Livonia, MI NDC 0904-6509-04
Reason
Superpotent Drug; out of specification results for assay (manufacturer)
Identifiers
| code_info | LOT: T-00601 Exp: 04-2017 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0692-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.