FDA recall D-0493-2022

Product

PAINAID BRF Back Relief Formula (acetaminophen 250 mg, caffeine 50 mg, Magnesium salicylate 290 mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-0003-00

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-0493-2022