Drug & medication recalls Moderate risk

Multi Symptom Cold Relief tablets 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 Multi Symptom Cold Relief (acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) t…
Recall number
D-0478-2022
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

Multi Symptom Cold Relief (acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917

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