FDA recall D-0624-2021

Medline Industries Inc · Class III · drug

Product

READYPREP CHG, 2% Chlorhexidine Gluconate Cloth, 2 9x10.5 in (22.9x26.7 cm) Disposable Cloths, Non-Sterile, Single Use Only, Manufactured by Medline Industries, Inc., Northfield, IL 60093 USA. NDC: 53329-244-01

Reason for recall

Superpotent Drug: Product is above specification for active ingredient, 2% Chlorhexidine Gluconate.

Distribution

Distributed Nationwide in the USA and Isreal

Key facts

Status
Terminated
Initiation date
2021-05-14
Report date
2021-06-16
Termination date
2024-08-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0624-2021