FDA-Drug2024-02-07Class II
Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 0591-2510-30
Teva Pharmaceuticals USA, Inc
Hazard
Failed Dissolution Specifications
Sold states
Nationwide
Affected count
10,672 30-count bottles
Manufactured in
400 Interpace Pkwy Bldg A, Parsippany, NJ, United States
Products
Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 0591-2510-30
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0275-2024Don't want to check this manually?
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