FDAFDA · Food and drugs·Recall number D-0275-2024
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
Published February 7, 2024 · Recall initiated: January 8, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- BUDESONIDE
- Manufacturer
- Teva Pharmaceuticals USA, Inc
- Distributor
- Nationwide
- UPC
- 0305912510303
- Lot
- Lot # 100047273; Exp. 07/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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