Apotex Inc. recalls Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario C…

Recall date

October 22, 2019

Source

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

Recall number

D-0153-2020

FDA classification

Class III

Brand / firm

Apotex Inc.

Sold / distributed

IL, MS, NJ, OH, TX

Why it was recalled

Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg.

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

What was recalled

Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-2580-8