Drug product
Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2997-3; UPC # 360505299737;
D-1436-2016
Product summary
- Event
- Event 73419
- Status
- Terminated
- Classification
- Class III
- Quantity
- 605,989 (30 ct) bottles
- Official record key
drug-enforcement:D-1436-2016
Official wording
Reason: Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Code information: Lot #: KW2167,KY9960, KV9789, KV9788; Exp 02/29/2016; Lot #: KY9961, Exp 04/30/2016; Lot #: KX6311, KX6312, KY7795, KX6315, Exp 05/31/2016; Lot #: KX6317, Exp 06/30/2016.
Distribution pattern: Nationwide, Alaska, Hawaii, and Puerto Rico.
Derived failure modes
-
Potency or specification failure
Out of specification