Drug Enforcement D-0169-2024

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Status

Terminated

Classification

Class II

Report Date

January 3, 2024

Termination Date

September 29, 2024

Product Information

Product description
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
Product quantity
3 units
Reason for recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide USA

Location & Firm

Recalling firm
CARDINAL HEALTHCARE
Address
7200 Cardinal Pl W

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

Codes & Dates

Recall number
D-0169-2024
Event ID
89450
Recall initiation date
January 26, 2022
Center classification date
December 26, 2023
Code info
Batch U027458
More code info
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