US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jul 19, 2019 (7 years ago)

Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b) 500 count…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Failed Dissolution Specifications

What was recalled

Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b) 500 count (NDC 67877-0514-05) bottles, Rx only, Manufactured by: Alkem Laboratories, Ltd, Mumbai INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ

Recalling firm
Ascend Laboratories LLC
NDC code
67877-0514-90
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1515-2019

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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