PlainRecalls
FDA Drug Moderate Class II Terminated

Budesonide Extended-Release Tablets, 9 mg, 30-count bottles, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA, UPC 5140782430, NDC 51407-824-30

Reported: February 7, 2024 Initiated: January 12, 2024 #D-0276-2024

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

Reason for Recall

Failed Dissolution Specifications

Details

Units Affected
108 bottles
Distribution
Illinois only
Location
Camarillo, CA

Frequently Asked Questions

What product was recalled?
Budesonide Extended-Release Tablets, 9 mg, 30-count bottles, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA, UPC 5140782430, NDC 51407-824-30. Recalled by Golden State Medical Supply Inc.. Units affected: 108 bottles.
Why was this product recalled?
Failed Dissolution Specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on February 7, 2024. Severity: Moderate. Recall number: D-0276-2024.