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

Recall Number: D-0070-2021

Firm: AVKARE Inc.

Classification: Class II

Status: Terminated

Report Date: 20201118

Initiation Date: 20201030

Termination Date: 20230602

Reason for Recall

Failed Dissolution Specifications

Product Description

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