FDA Drug recall D-1437-2016
Duloxetine Delayed-Release Capsules, USP, 30 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactu…
- FDA Drug
- Class III
- terminated
- Published 2016-07-20
On 2016-07-20 the FDA classified a Class III recall of Duloxetine Delayed-Release Capsules, USP, 30 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactu… by Apotex Scientific, citing failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1437-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-01-26 |
| Published | 2016-07-20 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Apotex Scientific |
| Distribution | US |
Product
Duloxetine Delayed-Release Capsules, USP, 30 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2996-3; UPC # 360505299638.
Reason
Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Identifiers
| upc | 360505299638 |
|---|---|
| code_info | Lot #: KY5120, KW2164, KY9953, KV9791, KV9792, Exp 03/31/2016. |
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-1437-2016%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.