Unlikely to cause harm — often a labeling or packaging issue.
Failed Impurities/Degradation Specifications: Out of Specification results for related substance.
| Brand name | ATORVASTATIN CALCIUM |
| Generic name | ATORVASTATIN CALCIUM |
| Active ingredient(s) | ATORVASTATIN CALCIUM TRIHYDRATE |
| Distributed by / for | Dr. Reddy's Laboratories, Inc. |
| NDC | 55111-124-90 |
| Full product label | Atorvstatin Calcium Tablets, USP 80 mg*, 90 Tablets, Rx Only, Mrd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, INDIA, NDC 55111-124-90 |
| Recalling firm | Dr. Reddy's Laboratories, Inc. |
| Distribution | Nationwide in the USA. |
| Quantity | 28,068 bottles |
| Recall initiated | 2022-03-16 |
| Report date | 2022-04-06 |
| Recall completed | 2023-11-13 |
| Recall number | D-0726-2022 |
| Classification | Class III |
| FDA status | Terminated |
| Origin on file | Princeton NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗