FDA recall D-0475-2022
Ultra Seal Corporation · Class II · drug
Product
MidNite Sleep Health (melatonin 1.5 mg) tablets, 30-count bottles, Distributed by: Mylan Consumer Healthcare, Inc. Morgantown, WV 26505 USA
Reason for recall
cGMP deviations
Distribution
Nationwide within the United States
Key facts
- Status
- Terminated
- Initiation date
- 2022-01-24
- Report date
- 2022-02-09
- Termination date
- 2023-10-16
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- New Paltz, NY, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0475-2022