Apotex Scientific, Inc recalls Duloxetine Delayed-Release Capsules, USP, 30 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontar
Recalled July 20, 2016 · FDA recall D-1437-2016 · Apotex Scientific
Hazard
Failed Dissolution Specification: Out of specification dissolution results when testing product stability. · FDA Class III
Units
750,273 (30 ct) bottles
Sold at
Nationwide, Alaska, Hawaii, and Puerto Rico.
Description
Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
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.
Manufacturer(s)
Apotex Scientific, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →