Budesonide Extended-Release Tablets recalled for failed dissolution specifications
Golden State Medical Supply Inc. is recalling 108 bottles of Budesonide Extended-Release Tablets (9 mg) distributed in Illinois due to failed dissolution specifications.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a prescription medication with a manufacturing defect in dissolution specifications. No illnesses or injuries are reported in the source material, but the defect represents a risk of harm through potentially altered drug effectiveness.
Plain-English summary
Golden State Medical Supply Inc. is recalling Budesonide Extended-Release Tablets, 9 mg, 30-count bottles, due to failed dissolution specifications. The recalled lot is Lot #GS054862 with an expiration date of 07/31/2025.
A total of 108 bottles were distributed in Illinois. This is a prescription medication marketed by GSMS, Incorporated, Camarillo, CA.
Patients taking this medication from the recalled lot should contact their healthcare provider or pharmacist. Consumers should not use this product and should consult their healthcare provider about appropriate alternatives.
The recalled product
- Product
- Budesonide Extended-Release Tablets, 9 mg, 30-count bottles, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA, UPC 5140782430, NDC 51407-824-30
- Manufacturer
- Golden State Medical Supply Inc.
- Category
- Drug
- Hazard
- Affected units
- 108
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: GS054862
- Exp. Date 07/31/2025
Distribution
Distributed in 1 state:
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