Budesonide, USP (Micronized), 500 mg, White to off-white odo… recall — Class II (D-0570-2024) · pharmaranks
Class IICompleted
Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Med… recall
FDA recall D-0570-2024 · initiated Jun 26, 2024
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations and Presence of Particulate Matter: Glass
Details
Product
Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca Inc., Plattsburgh, NY, 12901, USA, NDC: 38779-3097-00.
Recalling company
Medisca Inc.
Classification
Class II
Status
Completed
Type
Voluntary: Firm initiated
Distribution
Nationwide in the USA and Canada
Initiated
Jun 26, 2024
FDA report date
Jul 10, 2024
What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.