Dologen caplets 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 Dologen (acetaminophen 325 mg and dexbrompheniramine maleate 1mg) caplets, packaged in a) 90-count bottles, b) 2-count…

Recall number

D-0474-2022

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

Dologen (acetaminophen 325 mg and dexbrompheniramine maleate 1mg) caplets, packaged in a) 90-count bottles, b) 2-count packets, Manufactured in the USA for Kramer-Novis, San Juan, Puerto Rico 00917, NDC 52083-482-02