Product: 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
Reason for recall: Failed Dissolution Specifications
Recall initiated: 20240108
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated