D-0153-2020 Class III Terminated
FDA drug recall D-0153-2020 was initiated by Apotex Inc. on Oct 22, 2019 and is designated Class III. Reason for recall: Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg. The recall status is terminated (terminated Feb 19, 2026). Affected quantity: 1968 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Nov 6, 2019
- Initiation Date
- Oct 22, 2019
- Termination Date
- Feb 19, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1968 bottles
Product description
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 pattern
IL, MS, NJ, OH, TX
Code information
Lot: RC5439 Exp. 03/2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0153-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026