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Budesonide Extended-Release Tablets, 9 mg, 30-count bottles, Rx only, Marketed by: GSMS, Incorpor...

FDA Recall #D-0276-2024 — Class II — January 12, 2024

Recall #D-0276-2024 Date: January 12, 2024 Classification: Class II Status: Terminated

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

Recalling Firm

Golden State Medical Supply Inc. — Camarillo, CA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

108 bottles

Distribution

Illinois only

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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