D-0070-2021 Class II Terminated
FDA drug recall D-0070-2021 was initiated by AVKARE Inc. on October 30, 2020 and is designated Class II. Reason for recall: Failed Dissolution Specifications The recall status is terminated (terminated June 2, 2023). Affected quantity: 15,678 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- November 18, 2020
- Initiation Date
- October 30, 2020
- Termination Date
- June 2, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15,678 bottles
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
Distribution Pattern
Nationwide
Code Information
Lots: 26085 Exp. 07/2021, 26426 Exp. 01/2022, 26983 Exp. 04/2022, 28647 Exp. 06/2022