Drug product
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
D-0888-2018
Product summary
- Event
- Event 80275
- Status
- Terminated
- Classification
- Class III
- Quantity
- 130,081 bottles
- Official record key
drug-enforcement:D-0888-2018
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot #: a) T600392, T600384, T600353, Exp 08/18; T600427, Exp 09/18; T600435, Exp 10/18; T600492, Exp 11/18; T700006, T700014, T700033, T700035, T700036 12/18; b) T600407, Exp 09/18
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications