Drug product
Atorvastatin Calcium Tablets, USP 10 mg, 500-count bottles, Rx Only, Dr. Reddy's Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, 500-090 India, NDC 55111-121-05.
D-0629-2021
Product summary
- Event
- Event 88041
- Status
- Terminated
- Classification
- Class III
- Quantity
- 5984 bottles
- Official record key
drug-enforcement:D-0629-2021
Official wording
Reason: Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities
Code information: Lot #: C905064, C905065, Exp. Date 07/2021
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications