SINU-PHEN PLUS sinus pain and congestion tabs 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 SINU-PHEN PLUS sinus pain and congestion tabs (acetaminophen 500 mg, Phenylephrine HCl 5.0 mg) 2 tablet packets, Manufa…

Recall number

D-0489-2022

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

SINU-PHEN PLUS sinus pain and congestion tabs (acetaminophen 500 mg, Phenylephrine HCl 5.0 mg) 2 tablet packets, Manufactured for: Tellus Medical Products, Palm Desert, CA 92211, NDC 69103-2536-00