Drug product
Atorvastatin Calcium Tablets, USP 10 mg*, Rx Only, 500 count bottle, Mfd By: Dr. Reddy's Laboratories Limited, Bachupally 500 090, India, NDC 55111-121-05.
D-0599-2021
Product summary
- Event
- Event 87879
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2980 500 count -bottles
- Official record key
drug-enforcement:D-0599-2021
Official wording
Reason: Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities
Code information: Lot # C905063, Exp 07/2021
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Unknown
Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities