Drug product
Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b) 500 count (NDC 67877-0514-05) bottles, Rx only, Manufactured by: Alkem Laboratories, Ltd, Mumbai INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ
D-1515-2019
Product summary
- Event
- Event 83378
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 5,472 bottles and b) 5,880 bottles
- Official record key
drug-enforcement:D-1515-2019
Official wording
Reason: Failed Dissolution Specifications
Code information: a) Lot# 19140443, exp. date 12/2020, Lot# 19140525, 19140535, exp. date 01/2021 and b) Lot# 19140756, exp. date 12/2020, Lot# 19140757, Lot# 19140758, exp. date 01/2021, Lot# 19141696, Lot# 19141793, exp. date 03/2021
Distribution pattern: Product was shipped to wholesalers throughout the United States.
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications