Drug Enforcement D-0550-2024

Defective Container

Status

Ongoing

Classification

Class III

Report Date

June 19, 2024

Termination Date

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Product Information

Product description
Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 60 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-114-02
Product quantity
2,886 units
Reason for recall
Defective Container
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Organon Llc
Address
30 Hudson St Fl 33, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0550-2024
Event ID
94703
Recall initiation date
May 28, 2024
Center classification date
June 10, 2024
Code info
Lot #: X025346, Exp 3/3/2025
More code info
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