Drug product
Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-121-05
D-0418-2018
Product summary
- Event
- Event 79065
- Status
- Terminated
- Classification
- Class III
- Quantity
- a) 34,125; b) 3,540 bottles
- Official record key
drug-enforcement:D-0418-2018
Official wording
Reason: Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Code information: Lot numbers: a) T600125, 3/2018; T600201, T600248 5/2018, b) T600125, 3/2018; T600201, and T600248, 5/2018
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out-of-specification