FDA-Drug2024-07-10Class II

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

Medisca Inc.
Hazard

CGMP Deviations and Presence of Particulate Matter: Glass

Sold states
Nationwide in the USA and Canada
Affected count
113 bottles
Manufactured in
6641 N Belt Line Rd Ste 130, N/A, Irving, TX, United States
Products
Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca Inc., Plattsburgh, NY, 12901, USA, NDC: 38779-3097-00.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0570-2024

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