FDA recall D-0506-2022

Ultra Seal Corporation · Class II · drug

Product

MidNite Natural sleep aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, BGP Pharma ULC, Etobicoke, ON M8Z 2S6

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-0506-2022