Drug product
Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-123-05
D-0420-2018
Product summary
- Event
- Event 79065
- Status
- Terminated
- Classification
- Class III
- Quantity
- 12,579 bottles
- Official record key
drug-enforcement:D-0420-2018
Official wording
Reason: Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Code information: Lot number: T600279, 6/2018
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out-of-specification