FDAFDA · Food and drugs·Recall number D-0862-2020
Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count 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 March 11, 2020 · Recall initiated: February 20, 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: Low out of specification dissolution result observed during stability testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- MESALAMINE
- Manufacturer
- Teva Pharmaceuticals USA
- Distributor
- Nationwide in the USA.
- UPC
- 0305912245229
- Lot
- Lot #: 1342500A, Exp 10/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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