Ultra Seal Corporation recalls Dologen (acetaminophen 325 mg and dexbrompheniramine maleate 1mg) caplets, packaged in a) 90-count bottles, b) 2-count p
Recalled February 9, 2022 · FDA recall D-0474-2022 · Ultra Seal
Hazard
cGMP deviations · FDA Class II
Units
a) 9,060 bottles, b) 44,700 packets
Sold at
Nationwide within the United States
Description
cGMP deviations
Product
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
Manufacturer(s)
Ultra Seal Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →