FDA recall D-0474-2021

Cardinal Health Inc. · Class II · drug

Product

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP 10-30-2MG/5ML 473ML; NDC/UPC 71930-026-43; RX; SYRUP

Reason for recall

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Distribution

FL, GA, SC

Key facts

Status: Terminated
Initiation date: 2021-03-15
Report date: 2021-06-02
Termination date: 2024-06-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Dublin, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0474-2021