FDAFDA · Food and drugs·Recall number D-0070-2021
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
Published November 18, 2020 · Recall initiated: October 30, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- AVKARE Inc.
- Distributor
- Nationwide
- Lot
- Lots: 26085 Exp. 07/2021, 26426 Exp. 01/2022, 26983 Exp. 04/2022, 28647 Exp. 06/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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