Why it was recalled
Failed Dissolution Specifications
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
Lot numbers, UPCs & expiration codes
Lot # 100047273; Exp. 07/2025
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0275-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jan 8, 2024
- FDA report date
- Feb 7, 2024
- Quantity
- 10,672 30-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA, Inc
Original FDA data
Every field from FDA enforcement report D-0275-2024, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 93740
- Address
- 400 Interpace Pkwy Bldg A
- Code information
- Lot # 100047273; Exp. 07/2025
- Postal code
- 07054-1120
- Report date
- Feb 7, 2024
- Product type
- Drugs
- Recall number
- D-0275-2024
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA, Inc
- Product quantity
- 10,672 30-count bottles
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 8, 2024
- Initial firm notification
- Letter
- Center classification date
- Jan 26, 2024