Ascend Laboratories LLC recalls Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b) 500 count (NDC 67877-0514-05) bottles, Rx…

Recall date

July 19, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1515-2019

FDA classification

Class II

Brand / firm

Ascend Laboratories LLC

Sold / distributed

Product was shipped to wholesalers throughout the United States.

Why it was recalled

Failed Dissolution Specifications

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

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