FDA-Drug2022-02-09Class II
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
Ultra Seal Corporation
Hazard
cGMP deviations
Sold states
Nationwide within the United States
Affected count
a) 9,060 bottles, b) 44,700 packets
Manufactured in
521 Main St, N/A, New Paltz, NY, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0474-2022Don't want to check this manually?
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