Drug product

Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054

D-0020-2026

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-0020-2026

Official wording

Reason: Failed Dissolution Specifications

Code information: Lot#: 25140249, Exp. Dec. 2026 Lot#: 25140247, Exp. Dec. 2026 Lot#: 24144999, Exp. Nov. 2026 Lot#: 24144942, Exp. Nov. 2026 Lot#: 24144845, Exp. Nov. 2026 Lot#: 24144713, Exp. Nov. 2026 Lot#: 24144652, Exp. Oct. 2026 Lot#: 24143898, Exp. Aug. 2026 Lot#: 24143412, Exp. Aug. 2026 Lot#: 24143582, Exp. Aug. 2026

Distribution pattern: U.S. Nationwide

Derived failure modes

Potency or specification failure
reason.potency_specification_failure · v1.0.0

Failed Dissolution Specifications