Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
PULMICORT RESPULES 0.25 mg/2 ml Budesonide Inhalation Suspension (30 ampules/carton) NDC: 0186-1988-04
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 within the ampoule solution
Reason Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Reason Defective delivery system
Reason CGMP Deviations and Presence of Particulate Matter: Glass
Reason Failed Dissolution Specifications
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