Unlikely to cause harm — often a labeling or packaging issue.
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
| Brand name | ATORVASTATIN CALCIUM |
| Generic name | ATORVASTATIN CALCIUM |
| Active ingredient(s) | ATORVASTATIN CALCIUM TRIHYDRATE |
| Distributed by / for | Dr. Reddy's Laboratories, Inc. |
| NDC | 55111-123-05 |
| Full product label | Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-123-05 |
| Recalling firm | Dr. Reddy's Laboratories, Inc. |
| Distribution | Nationwide |
| Quantity | 12,579 bottles |
| Recall initiated | 2018-01-29 |
| Report date | 2018-02-07 |
| Recall completed | 2018-12-07 |
| Recall number | D-0420-2018 |
| 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 ↗