Ultra Seal Corporation: Drug Recall

Recall #D-0470-2022 · 01/24/2022

Class II: Risk

Recall Details

Recall Number
D-0470-2022
Classification
Class II
Product Type
Drug
Recalling Firm
Ultra Seal Corporation
Status
Terminated
Date Initiated
01/24/2022
Location
New Paltz, NY, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
174,852 bottles

Reason for Recall

cGMP deviations

Product Description

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

Distribution Pattern

Nationwide within the United States

Other Recalls by Ultra Seal Corporation

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Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.