January 2024 FDA Recall Drug by Golden State Medical Supply Inc.
D-0276-2024 - Failed Dissolution Specifications

This Class II drug recall was voluntarily initiated by Golden State Medical Supply Inc. on January 12, 2024 for the product Drug. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed in Illinois only and the recall is currently terminated.

Recall Number: D-0276-2024

Reason for Recall
Failed Dissolution Specifications
Initiated
01-12-2024
Reported
02-07-2024
Quantity
108 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93827
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Golden State Medical Supply Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Illinois only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-20-2025
Product Description About Product Description
Full technical description of the product.
Budesonide Extended-Release Tablets, 9 mg, 30-count bottles, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA, UPC 5140782430, NDC 51407-824-30

Batch or Lot Expiration Information

Lot# : GS054862, Exp. Date 07/31/2025