D-0275-2024 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- February 7, 2024
- Initiation Date
- January 8, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,672 30-count bottles
Product Description
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
Distribution Pattern
Nationwide
Code Information
Lot # 100047273; Exp. 07/2025