Teva Pharmaceuticals USA recalls Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx Only, Manufactured by: Actavis Laboratorie…
- Recall date
- October 28, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0069-2021
- FDA classification
- Class II
- Brand / firm
- Teva Pharmaceuticals USA
- Sold / distributed
- Nationwide in the U.S. and PR
Why it was recalled
Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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