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Drug FDA Class II Completed Foreign material

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

Medisca Inc. Published Jul 10, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 55/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Medisca Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

CGMP Deviations and Presence of Particulate Matter: Glass

Hazards

Glass Particulate · primary

Affected products (1)

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

113 bottles

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

Affected areas

Nationwide

Timeline

  1. Initiated
    Jun 26, 2024
  2. Published
    Jul 10, 2024
Recall number
D-0570-2024
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.