May 2021 FDA Recall Readyprep Chg by Medline Industries Inc
D-0624-2021 - Superpotent Drug
This Class III drug recall was voluntarily initiated by Medline Industries Inc on May 14, 2021 for the product Readyprep Chg. The FDA reported the reason for recall as superpotent drug. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0624-2021
Superpotent Drug: Product is above specification for active ingredient, 2% Chlorhexidine Gluconate.
05-14-2021
06-16-2021
231,936 packs
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Medline Industries Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed Nationwide in the USA and Isreal
08-07-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# :: 19EEA027, Exp May 2021; 19GEA049, Exp August 2021; 19HEA044, Exp Sept 2021
