FDA recall D-0470-2022

Ultra Seal Corporation · Class II · drug

Product

Legatrin PM Pain Reliever/Sleep Aid (acetaminophen 500 mg, diphenhydramine HCl 50mg caplets) 50-count bottles, Manufactured for: Church & Dwight Co., Inc. Ewing, NJ 08628 NDC 10237-907-50

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-0470-2022