Drug product
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
D-0886-2018
Product summary
- Event
- Event 80275
- Status
- Terminated
- Classification
- Class III
- Quantity
- 55,126 bottles
- Official record key
drug-enforcement:D-0886-2018
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot #: T600327, Exp 07/18; T700213, T700215, Exp 04/19
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications