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Recall Observatory FDA recall evidence

Drug product

Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 14 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-114-03

D-0551-2024

May 28, 2024

Class III

Product summary

Firm
Organon Llc
Event
Event 94703
Status
Ongoing
Classification
Class III
Quantity
2,551 units
Official record key
drug-enforcement:D-0551-2024

Official wording

Reason: Defective Container

Code information: Lot #: X024051, Exp 04/25/2025

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Defective Container