Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Processing Controls
All budesonide Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
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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