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Ascend Laboratories, LLC: 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-co

DrugsSource: FDA (drug) · Date: 2025-10-22

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Ascend Laboratories, LLC
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.
Reason / hazard
Failed Dissolution Specifications
Classification
Class II
Status
Ongoing
Distribution / sold at
U.S. Nationwide
Recall initiated
2025-09-19
Code info
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
Product quantity
141,984 bottles
Voluntary mandated
Voluntary: Firm initiated
City
Bedminster
State
NJ
Country
United States
Event id
97639
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