FDA Drug recall D-0153-2020
Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manufactured by: Apotex Inc
- FDA Drug
- Class III
- terminated
- Published 2019-11-06
On 2019-11-06 the FDA classified a Class III recall of Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manufactured by: Apotex Inc by Apotex, citing presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0153-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-10-22 |
| Published | 2019-11-06 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Apotex |
| Distribution | IL, MS, NJ, OH, TX |
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
Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg.
Identifiers
| ndc | 60505-2578-3 |
|---|---|
| ndc | 60505-2578-9 |
| ndc | 60505-2578-5 |
| ndc | 60505-2578-8 |
| ndc | 60505-2578-7 |
| ndc | 60505-2578-0 |
| ndc | 60505-2579-3 |
| ndc | 60505-2579-9 |
| ndc | 60505-2579-5 |
| ndc | 60505-2579-8 |
| ndc | 60505-2579-7 |
| ndc | 60505-2579-0 |
| ndc | 60505-2580-3 |
| ndc | 60505-2580-9 |
| ndc | 60505-2580-5 |
| ndc | 60505-2580-8 |
| ndc | 60505-2580-7 |
| ndc | 60505-2580-0 |
| ndc | 60505-2671-3 |
| ndc | 60505-2671-9 |
| ndc | 60505-2671-5 |
| ndc | 60505-2671-8 |
| ndc | 60505-2671-7 |
| ndc | 60505-2671-0 |
| code_info | Lot: RC5439 Exp. 03/2022 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0153-2020%22
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