Drug product
Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-count bottle (NDC 67877-511-05), c). 1000-count bottle (NDC 67877-511-10) Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
D-0017-2026
Product summary
- Event
- Event 97639
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 141,984 bottles
- Official record key
drug-enforcement:D-0017-2026
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot#: 25141249, Exp. Feb. 2027 Lot#: 24144938, Exp. Nov. 2026 Lot#: 24144868, Exp. Nov. 2026 Lot#: 24144867, Exp. Nov. 2026 Lot#: 24144458, Exp. Sep. 2026 Lot#: 24143994, Exp. Sep. 2026 Lot#: 24142987, Exp. July 2026 Lot#: 24143316, Exp. July 2026
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications