Why it was recalled
Failed Dissolution Specifications
Product description
Budesonide Extended-Release Tablets, 9 mg, 30-count bottles, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA, UPC 5140782430, NDC 51407-824-30
Lot numbers, UPCs & expiration codes
Lot #: GS054862, Exp. Date 07/31/2025
Where it was sold
Illinois only
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-0276-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 12, 2024
- FDA report date
- Feb 7, 2024
- Quantity
- 108 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Golden State Medical Supply Inc.
Original FDA data
Every field from FDA enforcement report D-0276-2024, exactly as published.
Show all FDA fields
- City
- Camarillo
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 93827
- Address
- 5187 Camino Ruiz
- Code information
- Lot #: GS054862, Exp. Date 07/31/2025
- Postal code
- 93012-8601
- Report date
- Feb 7, 2024
- Product type
- Drugs
- Recall number
- D-0276-2024
- Classification
- Class II
- Recalling firm
- Golden State Medical Supply Inc.
- Product quantity
- 108 bottles
- Termination date
- Mar 20, 2025
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Budesonide Extended-Release Tablets, 9 mg, 30-count bottles, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA, UPC 5140782430, NDC 51407-824-30
- Distribution pattern
- Illinois only
- Recall initiation date
- Jan 12, 2024
- Initial firm notification
- Letter
- Center classification date
- Jan 29, 2024