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
FDA recall notice · announced February 7, 2024 · Teva Pharmaceuticals
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The 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
Notes
Distribution: Nationwide
Lot/code information: Lot # 100047273; Exp. 07/2025
Quantity: 10,672 30-count bottles
Status: Ongoing
Products in this recall event:
- 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 0 (D-0275-2024)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.