FDA recall D-0474-2022

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

Reason for recall

cGMP deviations

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2022-01-24

Report date

2022-02-09

Termination date

2023-10-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

New Paltz, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0474-2022