Drug Enforcement D-0276-2024

Failed Dissolution Specifications

Status

Terminated

Classification

Class II

Report Date

February 7, 2024

Termination Date

March 20, 2025

Product Information

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
Product quantity
108 bottles
Reason for recall
Failed Dissolution Specifications
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Illinois only

Location & Firm

Recalling firm
Golden State Medical Supply Inc.
Address
5187 Camino Ruiz

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0276-2024
Event ID
93827
Recall initiation date
January 12, 2024
Center classification date
January 29, 2024
Code info
Lot #: GS054862, Exp. Date 07/31/2025
More code info
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