READYPREP CHG recalled over sterility concerns

Recall date

May 14, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Medline Industries Inc recalls READYPREP CHG, 2% Chlorhexidine Gluconate Cloth, 2 9x10.5 in (22.9x26.7 cm) Disposable Cloths, Non-Sterile, Single Use…

Recall number

D-0624-2021

FDA classification

Class III

Brand / firm

Medline Industries Inc

Sold / distributed

Distributed Nationwide in the USA and Isreal

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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