Multi event Drug Recall Enforcement Report Class III voluntary initiated by Dr. Reddy's Laboratories, Inc., originally initiated on 06-12-2018 for the product Atorvastatin Calcium Tablets, 20 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-122-90 The product was recalled due to failed impurities/degradation specifications. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0887-2018 | 06-12-2018 | 06-27-2018 | Class III | 44,894 bottles | Atorvastatin Calcium Tablets, 20 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-122-90 | Failed Impurities/Degradation Specifications | Terminated |
| D-0886-2018 | 06-12-2018 | 06-27-2018 | Class III | 55,126 bottles | Atorvastatin Calcium Tablets, 10 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-121-90 | Failed Impurities/Degradation Specifications | Terminated |
| D-0888-2018 | 06-12-2018 | 06-27-2018 | Class III | 130,081 bottles | Atorvastatin Calcium Tablets, 40 mg*, packaged as a) 90-count bottle (NDC 55111-123-90 and b) 500-count bottle (NDC 55111-123-05), Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA | Failed Impurities/Degradation Specifications | Terminated |
Recalled Products
