Legatrin PM Pain Reliever/Sleep Aid bottles recalled over manufacturing violations
- Recall date
- January 24, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Ultra Seal Corporation recalls Legatrin PM Pain Reliever/Sleep Aid (acetaminophen 500 mg, diphenhydramine HCl 50mg caplets) 50-count bottles, Manufact…
- Recall number
- D-0470-2022
- FDA classification
- Class II
- Brand / firm
- Ultra Seal Corporation
- Sold / distributed
- Nationwide within the United States
Why it was recalled
cGMP deviations
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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