FDA-Drug2020-03-11Class II
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.
Teva Pharmaceuticals USA
Hazard
Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.
Sold states
Nationwide in the USA.
Affected count
3,695 bottles
Manufactured in
400 Interpace Pkwy, N/A, Parsippany, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0862-2020Don't want to check this manually?
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