FDA recall D-0153-2020

Product

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

Reason for recall

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

Distribution

IL, MS, NJ, OH, TX

Key facts

Status

Terminated

Initiation date

2019-10-22

Report date

2019-11-06

Termination date

2026-02-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

North York, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0153-2020