Drug product
Budesonide Extended-Release Tablets, 9 mg, 30-count bottles, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA, UPC 5140782430, NDC 51407-824-30
D-0276-2024
Product summary
- Event
- Event 93827
- Status
- Terminated
- Classification
- Class II
- Quantity
- 108 bottles
- Official record key
drug-enforcement:D-0276-2024
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot #: GS054862, Exp. Date 07/31/2025
Distribution pattern: Illinois only
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications