Teva Pharmaceuticals USA recalls Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL,…
- Recall date
- February 20, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0862-2020
- FDA classification
- Class II
- Brand / firm
- Teva Pharmaceuticals USA
- Sold / distributed
- Nationwide in the USA.
Why it was recalled
Failed Dissolution Specifications: Low out of specification dissolution result observed 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-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.
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