Drug product
Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 India, NDC 55111-123-05
D-1079-2018
Product summary
- Event
- Event 80675
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2280 bottles
- Official record key
drug-enforcement:D-1079-2018
Official wording
Reason: Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in Atorvastatin Calcium Tablets 40 mg 500 tablets.
Code information: T60045
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications