Drug product

Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90), b). 500-count (NDC 67877-512-05), c). 1000-count(NDC 67877-512-10),Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.

D-0019-2026

September 19, 2025

Class II

Product summary

Firm: Ascend Laboratories, LLC
Event: Event 97639
Status: Ongoing
Classification: Class II
Quantity: Unavailable
Official record key: drug-enforcement:D-0019-2026

Official wording

Reason: Failed Dissolution Specifications

Code information: Lot #: 25140150, Exp. Dec. 2026 Lot #: 25140173, Exp. Dec. 2026 Lot #: 25140172, Exp. Dec. 2026 Lot #: 24144720, Exp. Nov. 2026 Lot #: 24144798, Exp. Nov. 2026 Lot #: 24144692, Exp. Oct. 2026 Lot #: 24143755, Exp. Aug. 2026 Lot #: 24143913, Exp. Aug. 2026 Lot #: 24143754, Exp. Aug. 2026 Lot #: 24143047, Exp. June 2026 Lot #: 24142936, Exp. July 2026

Distribution pattern: U.S. Nationwide

Derived failure modes

Potency or specification failure
reason.potency_specification_failure · v1.0.0

Failed Dissolution Specifications