Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Asmanex Twisthaler (mometasone furoate inhalation powder, 220 mcg per actuation), 120 Metered Doses, Rx only, Manufactured for: Organon LLC, a subsidiary of Organon & Co., Jersey City, NJ 07302; Manufactured by: MSD International GmbH (Singapore Branch) Singapore 638030, Singapore. NDC: 78206-114-01
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 Defective Delivery System: The dip tube is clogged causing the spray not to work.
Reason Defective Container
Reason Defective Container
Reason Defective Container
Reason Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9…
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