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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Topical Products

Medline Industries Inc: READYPREP CHG Cloths Recalled for Superpotent Active Ingredient

Agency Publication Date: June 10, 2021
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Summary

Medline Industries Inc. is recalling approximately 231,936 packs of READYPREP CHG 2% Chlorhexidine Gluconate Cloths because they contain more than the specified amount of the active ingredient, chlorhexidine gluconate. These single-use, disposable cloths were distributed nationwide in the United States and Israel for use in skin preparation. Consumers who have these cloths should be aware that the superpotent formula may lead to unintended skin reactions.

Risk

The product contains levels of the active ingredient that exceed the required specification, which can cause increased skin irritation or more severe adverse skin reactions.

What You Should Do

  1. Check your product packaging for the name 'READYPREP CHG 2% Chlorhexidine Gluconate Cloth' in the 2-cloth pack (9x10.5 in).
  2. Verify if your product is affected by looking for NDC: 53329-244-01 and Lot numbers 19EEA027 (Exp May 2021), 19GEA049 (Exp August 2021), or 19HEA044 (Exp Sept 2021).
  3. Immediately stop using any cloths from the affected lots.
  4. Contact your healthcare provider or pharmacist for guidance if you have used this product and have concerns or experienced skin irritation.
  5. Return any unused product to the place of purchase for a refund and contact Medline Industries Inc. for further instructions regarding the return process.
  6. For additional questions or to report a reaction, contact the FDA Consumer Complaint hotline at 1-888-723-3332.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Return any unused product to the pharmacy or original place of purchase for a refund and seek medical advice if necessary.

Affected Products

Product: READYPREP CHG 2% Chlorhexidine Gluconate Cloth (2-pack)
Model:
NDC: 53329-244-01
Recall #: D-0624-2021
Lot Numbers:
19EEA027 (Exp May 2021)
19GEA049 (Exp August 2021)
19HEA044 (Exp Sept 2021)
Date Ranges: May 2021, August 2021, September 2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88005
Status: Resolved
Manufacturer: Medline Industries Inc
Manufactured In: United States
Units Affected: 231,936 packs
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.