FDA recall D-0498-2022

Ultra Seal Corporation · Class II · drug

Product

Regular Strength Pain Reliever (acetaminophen 110 mg, aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) 2 tablet packets, Mfg for Advanced First Aid, Baltimore, MD 21237, NDC 67060-0113-00

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-0498-2022