Drug & medication recalls Moderate risk

AERO TAB Cold Relief 2 tablet packets 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 AERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg. for: Aero…
Recall number
D-0466-2022
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

AERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989

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