FDAClass IIJuly 10, 2024

Budesonide recall: Particulate Matter

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

Why was Budesonide recalled?

CGMP Deviations and Presence of Particulate Matter: Glass

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca Inc., Plattsburgh, NY, 12901, USA, NDC: 38779-3097-00.
Recalling firm
Medisca Inc.
Quantity
113 bottles
Distribution
Nationwide in the USA and Canada
Recall date
July 10, 2024
Classification
Class II
Status
Completed
Agency
FDA (drug)
Open FDA enforcement record Latest recalls