Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations and Presence of Particulate Matter: Glass
Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca Inc., Plattsburgh, NY, 12901, USA, NDC: 38779-3097-00.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles…
Reason Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Reason Defective delivery system
Reason Failed Dissolution Specifications
Reason Failed Dissolution Specifications
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