Multi event Drug Recall Enforcement Report Class III voluntary initiated by Dr. Reddy's Laboratories, Inc., originally initiated on 01-29-2018 for the product Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-121-05 The product was recalled due to failed impurities/degradations specifications; out-of-specification results observed for total degradation impurities during stability. 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-0418-2018 | 01-29-2018 | 02-07-2018 | Class III | a) 34,125; b) 3,540 bottles | Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-121-05 | Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability | Terminated |
| D-0419-2018 | 01-29-2018 | 02-07-2018 | Class III | a) 28,941 and b) 2,928 bottles | Atorvastatin Calcium Tablets 20 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-122-05 | Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability | Terminated |
| D-0420-2018 | 01-29-2018 | 02-07-2018 | Class III | 12,579 bottles | Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-123-05 | Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability | Terminated |
Recalled Products
