FDAFDA · Food and drugs·Recall number D-0069-2021
Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories, FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma Inc., Parsippany, NJ 07054, NDC 0591-2245-22.
Published November 18, 2020 · Recall initiated: October 28, 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: Out-of-specification dissolution results were obtained during stability testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- MESALAMINE
- Manufacturer
- Teva Pharmaceuticals USA
- Distributor
- Nationwide in the U.S. and PR
- UPC
- 0305912245229
- Lot
- Lot #s: 1342498A, Exp. 12/2020; 1342499A, Exp. 01/2021; 1354638A, Exp. 03/2021; 1354639A, 1358274A, 1358448A, 1364618A, 1369884A, Exp. 05/2021; 1366195A, 1369885A, 1373570A, Exp. 06/2021; 1373571A, Exp. 07/2021; 1388571A, Exp. 01/2022; 1395725A, 1396585A, 1397550A, 1399389A, Exp. 04/2022; 1403885A, 1403886A, Exp. 06/2022.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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