Drug & medication recalls Moderate risk

Nasal & Sinus Decongestant 2 tablets per packet 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 Nasal & Sinus Decongestant (phenylephrine HCl 5mg) 2 tablets per packet, Mfd. for Cintas First Aid & Safety, Mason OH 4…
Recall number
D-0464-2022
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

Nasal & Sinus Decongestant (phenylephrine HCl 5mg) 2 tablets per packet, Mfd. for Cintas First Aid & Safety, Mason OH 45040

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