Drug product
Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count (NDC 67877-513-05), c). 1000-count (NDC 67877-513-10), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
D-0018-2026
Product summary
- Event
- Event 97639
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0018-2026
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot#: 25140933, Exp. Feb. 2027 Lot#: 25140477, Exp. Dec. 2026 Lot#: 24144254, Exp. Oct. 2026 Lot#: 24144163, Exp. Sep. 2026 Lot#: 24143995, Exp. Sep. 2026
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications