Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
Fluticasone Propionate Nasal Spray USP, 50 mcg per spray, 120 metered sprays, 16 g net fill, Rx only, Manufactured by: Apotek Inc., Toronto, Ontario, Cananda, Marketed by: GSMS Incorporated, Camarillo, CA, NDC 60429-195-15
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 CGMP Deviations: potential presence of Burkholderia cepacia complex
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason Defective container: defect prevents product from dispensing as intended.
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
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