Ultra Seal Corporation: Drug Recall

Recall #D-0468-2022 · 01/24/2022

Class II: Risk

Recall Details

Recall Number
D-0468-2022
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
225,350 packets

Reason for Recall

cGMP deviations

Product Description

CHLORESIN (acetaminophen 325mg, dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Manufactured For Afassco Inc. Minden NV 89423, NDC 51532-0107-2

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.