FDA recall D-0482-2022

Ultra Seal Corporation · Class II · drug

Product

Backache & Muscle Relief (acetaminophen 250 mg, magnesium salicylate-tetrahydrate 290mg, caffeine 50 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-111-832

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-0482-2022