Drug product
Duloxetine Delayed-Release Capsules, USP, 20 mg, 60-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2995-6; UPC # 360505299560;
D-1435-2016
Product summary
- Event
- Event 73419
- Status
- Terminated
- Classification
- Class III
- Quantity
- 107,880 (60 ct bottle)
- Official record key
drug-enforcement:D-1435-2016
Official wording
Reason: Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Code information: Lot #: KV9795, KV9794, KV9796, KX6278; Exp 04/30/2016.
Distribution pattern: Nationwide, Alaska, Hawaii, and Puerto Rico.
Derived failure modes
-
Potency or specification failure
Out of specification