AVKARE Inc. recalls Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bottle, Rx Only Manufactured for: AvKARE, In…

Recall date

October 30, 2020

Source

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

Recall number

D-0070-2021

FDA classification

Class II

Brand / firm

AVKARE Inc.

Sold / distributed

Nationwide

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

Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bottle, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 NDC 42291-564-12