FDAJanuary 26, 2016drug

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;

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Failed Dissolution Specification: Out of specification dissolution results when testing product stability.

What to do

FDA enforcement status: Terminated

Brands named

apotex scientificapotex

UPCs

360505299737

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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