FDA recall D-0476-2022

Ultra Seal Corporation · Class II · drug

Product

Back Pain-Off (caffeine 50mg, magnesium salicylate 290mg) Tablets 2-count packets, Mfd for MEDIQUE PRODUCTS, Fort Myers, FL 33967, NDC 47682-073-00

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-0476-2022