US Drug Recall Register
Class III · Low risk Terminated Initiated Oct 22, 2019 (7 years ago)

Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manufactured by…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

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

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

Recalling firm
Apotex Inc.
NDC code
60505-2580-8
Origin
Canada
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0153-2020

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Atorvastatin recalls

See all