Drug 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
D-0153-2020
Product summary
- Firm
- Apotex Inc.
- Event
- Event 84107
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1968 bottles
- Official record key
drug-enforcement:D-0153-2020
Official wording
Reason: Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg.
Code information: Lot: RC5439 Exp. 03/2022
Distribution pattern: IL, MS, NJ, OH, TX
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets