Apotex Inc. recalls Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9;…

Recall date

December 19, 2016

Source

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

Recall number

D-0471-2017

FDA classification

Class III

Brand / firm

Apotex Inc.

Sold / distributed

Nationwide in the USA

Why it was recalled

Superpotent Drug: Product may not meet specifications throughout shelf life.

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

What was recalled

Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9; Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-3075-3.