FDA recall D-0467-2022

Ultra Seal Corporation · Class II · drug

Product

Maximum Strength Non Aspirin Pain Reliever/Fever Reducer (acetaminophen 500 mg) 2 tablet packets, Mfg. for: Advanced First Aid, Baltimore MD 21237, American Safety & First Aid, Osceola, IN 46561, NDC 67060-210-68

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-0467-2022