Apotex Scientific, Inc recalls Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontari…

Recall date

January 26, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1436-2016

FDA classification

Class III

Brand / firm

Apotex Scientific, Inc

Sold / distributed

Nationwide, Alaska, Hawaii, and Puerto Rico.

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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;