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
Reported: January 3, 2024 Initiated: January 26, 2022 #D-0169-2024
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
Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Details
- Recalling Firm
- CARDINAL HEALTHCARE
- Units Affected
- 3 units
- Distribution
- Nationwide USA
- Location
- Dublin, OH
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by CARDINAL HEALTHCARE. Units affected: 3 units.
Why was this product recalled? ▼
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 3, 2024. Severity: Moderate. Recall number: D-0169-2024.
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