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Recall Observatory FDA recall evidence

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

January 26, 2016

Class III

Product summary

Firm
Apotex Scientific, Inc
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

    reason.potency_specification_failure · v1.0.0

    Out of specification