Recalls / Class II
Class IID-0275-2024
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
- Brand name
- Budesonide
- Generic name
- Budesonide
- Active ingredient
- Budesonide
- Route
- Oral
- NDC
- 0591-2510
- FDA application
- ANDA205457
- Affected lot / code info
- Lot # 100047273; Exp. 07/2025
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Teva Pharmaceuticals USA, Inc
- Manufacturer
- Actavis Pharma, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy Bldg A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 10,672 30-count bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2024-01-08
- FDA classified
- 2024-01-26
- Posted by FDA
- 2024-02-07
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0275-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.