Recalls / Class II
Class IID-0276-2024
Product
Budesonide Extended-Release Tablets, 9 mg, 30-count bottles, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA, UPC 5140782430, NDC 51407-824-30
- Affected lot / code info
- Lot #: GS054862, Exp. Date 07/31/2025
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Golden State Medical Supply Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5187 Camino Ruiz, Camarillo, California 93012-8601
Distribution
- Quantity
- 108 bottles
- Distribution pattern
- Illinois only
Timeline
- Recall initiated
- 2024-01-12
- FDA classified
- 2024-01-29
- Posted by FDA
- 2024-02-07
- Terminated
- 2025-03-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0276-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.