Recalls / Class III
Class IIID-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
- Brand name
- Atorvastatin Calcium
- Generic name
- Atorvastatin Calcium
- Active ingredient
- Atorvastatin Calcium Propylene Glycol Solvate
- Route
- Oral
- NDCs
- 60505-2578, 60505-2579, 60505-2580, 60505-2671
- FDA application
- ANDA090548
- Affected lot / code info
- Lot: RC5439 Exp. 03/2022
Why it was recalled
Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg.
Recalling firm
- Firm
- Apotex Inc.
- Manufacturer
- Apotex Corp.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 150 Signet Drive, North York, N/A, Canada
Distribution
- Quantity
- 1968 bottles
- Distribution pattern
- IL, MS, NJ, OH, TX
Timeline
- Recall initiated
- 2019-10-22
- FDA classified
- 2019-10-28
- Posted by FDA
- 2019-11-06
- Terminated
- 2026-02-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0153-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.