October 2020 FDA Recall Drug by Avkare Inc.
D-0070-2021 - Failed Dissolution Specifications

This Class II drug recall was voluntarily initiated by Avkare Inc. on October 30, 2020 for the product Drug. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0070-2021

Reason for Recall
Failed Dissolution Specifications
Initiated
10-30-2020
Reported
11-18-2020
Quantity
15,678 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86695
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
AVKARE Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-02-2023
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# Lots: 26085 Exp. 07/2021, 26426 Exp. 01/2022, 26983 Exp. 04/2022, 28647 Exp. 06/2022