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FDARecalled Oct 22, 2025 · #D-0020-2026

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 Laboratori...

Hazard

Class II — temporary health risk

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Description

Failed Dissolution Specifications Classification: Class II Distribution: U.S. Nationwide

Product details

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
Type
Drugs
Manufacturer
Ascend Laboratories, LLC
Model numbers
25140249, 25140247, 24144999, 24144942, 24144845, 24144713, 24144652, 24143898, 24143412, 24143582
UPCs