FDA-Drug2020-11-18Class II
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.
Teva Pharmaceuticals USA
Hazard
Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.
Sold states
Nationwide in the U.S. and PR
Affected count
133,829 bottles
Manufactured in
400 Interpace Pkwy, Parsippany, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0069-2021Don't want to check this manually?
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