Drug product
Atorvstatin Calcium Tablets, USP 80 mg*, 90 Tablets, Rx Only, Mrd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, INDIA, NDC 55111-124-90
D-0726-2022
Product summary
- Event
- Event 89833
- Status
- Terminated
- Classification
- Class III
- Quantity
- 28,068 bottles
- Official record key
drug-enforcement:D-0726-2022
Official wording
Reason: Failed Impurities/Degradation Specifications: Out of Specification results for related substance.
Code information: Lot: T000707, T000756, T000758, T000759, Exp 03/2022; T2100600, T2101075, Exp. 1/2023; T2102802, Exp. 07/2023
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Out of Specification