Drug 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.
D-1437-2016
Product summary
- Event
- Event 73419
- Status
- Terminated
- Classification
- Class III
- Quantity
- 750,273 (30 ct) bottles
- Official record key
drug-enforcement:D-1437-2016
Official wording
Reason: Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Code information: Lot #: KY5120, KW2164, KY9953, KV9791, KV9792, Exp 03/31/2016.
Distribution pattern: Nationwide, Alaska, Hawaii, and Puerto Rico.
Derived failure modes
-
Potency or specification failure
Out of specification