FDA Recall D-0275-2024
Teva Pharmaceuticals USA, Inc · Parsippany, NJ
Class II Ongoing 857 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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 record
- Recall number
D-0275-2024- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide
- Recall initiated
- 2024-01-08
- Classified by FDA Center
- 2024-01-26
- FDA published
- 2024-02-07
- Recalling firm
- Teva Pharmaceuticals USA, Inc
- Firm location
- Parsippany, NJ
Drug identification
- Brand name(s)
- BUDESONIDE
- Generic name(s)
- BUDESONIDE
- Manufacturer(s)
- Actavis Pharma, Inc.
- NDC(s)
0591-2510- Route(s)
- ORAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.