Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bottle, Rx Only Manufa...
FDA Recall #D-0070-2021 — Class II — October 30, 2020
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
Reason for Recall
Failed Dissolution Specifications
Recalling Firm
AVKARE Inc. — Pulaski, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
15,678 bottles
Distribution
Nationwide
Code Information
Lots: 26085 Exp. 07/2021, 26426 Exp. 01/2022, 26983 Exp. 04/2022, 28647 Exp. 06/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated