FDA recall D-1089-2023

Parker Laboratories, Inc. · Class II · drug

Product

Protex Foaming Hand Sanitizer (Benzalkonium Chloride 0.13%), packaged in a) 2 fl oz/60 mL Pump bottles (NDC 30775-040-02) and b)18 fl. oz./550 ml Pump Bottles (NDC 30775-040-18), Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004

Reason for recall

CGMP Deviations

Distribution

Nationwide within the United States, Singapore, Korea and Hong Kong

Key facts

Status
Terminated
Initiation date
2023-08-02
Report date
2023-08-30
Termination date
2024-06-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Fairfield, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1089-2023