Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labelling: Illegible label
Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30x5 mL Sterile Unit-Dose Vials, Rx only, nephron 503B Outsourcing facility, 4600 12th Street Extension, West Columbia, SC 29172, NDC 69374-330-05.
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 Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the…
Reason Defective delivery system
Reason Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Reason Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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