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Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca In...

FDA Recall #D-0570-2024 — Class II — June 26, 2024

Recall #D-0570-2024 Date: June 26, 2024 Classification: Class II Status: Completed

Product Description

Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca Inc., Plattsburgh, NY, 12901, USA, NDC: 38779-3097-00.

Reason for Recall

CGMP Deviations and Presence of Particulate Matter: Glass

Recalling Firm

Medisca Inc. — Irving, TX

Classification

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

Product Type

Drugs

Product Quantity

113 bottles

Distribution

Nationwide in the USA and Canada

Code Information

Lot #s: 202323/G, 202323/H, Exp. 07/31/2026

Status

Completed

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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