FDA recall D-0497-2022

Product

Pain & Sinus Reliever Pain Reliever/Nasal Decongestant (acetaminophen 500mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg for Advanced First Aid, Baltimore, MD 21237, NDC 67060-194-68

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-0497-2022