FDA-Drug2022-02-09Class II

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

Ultra Seal Corporation
Hazard

cGMP deviations

Sold states
Nationwide within the United States
Affected count
174,852 bottles
Manufactured in
521 Main St, N/A, New Paltz, NY, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0470-2022

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