CLASS III Drug recall · Reported 16 Jun 2021 · FDA Enforcement Report
Readyprep CHG, 2% Chlorhexidine Gluconate Cloth recalled
Medline Industries is recalling Readyprep CHG, 2% Chlorhexidine Gluconate Cloth, 2 . Disposable Cloths, Non-Sterile, distributed nationwide in the US. The recall was initiated on 14 May 2021 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0624-2021
- FDA event ID
- 88005
- Recalling firm
- Medline Industries, Northfield, IL
- Brand
- Readyprep Chg
- Manufacturer
- Medline Industries, LP
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 14 May 2021
- FDA classified
- 10 Jun 2021
- Reported
- 16 Jun 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 14 May 2021 | Recall initiated by company | |
| 10 Jun 2021 | Classified by FDA | +27 days |
| 16 Jun 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Superpotent Drug: Product is above specification for active ingredient, 2% Chlorhexidine Gluconate.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Distributed Nationwide in the USA and Isreal
Questions about this recall
Why was it recalled?
Superpotent Drug: Product is above specification for active ingredient, 2% Chlorhexidine Gluconate.
Which lots are affected?
Lot #:: 19EEA027, Exp May 2021; 19GEA049, Exp August 2021; 19HEA044, Exp Sept 2021
Where was it sold?
Distributed Nationwide in the USA and Isreal
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Chlorhexidine Gluconate recalls
All 35| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | 2% Chlorhexidine Gluconate* Cloth, Non-sterile recalled by Sage ProductsChlorhexidine Gluconate | Sage Products | Other | Nationwide |
| Drug | CLASS II | BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate recalledChloraprep One-step | CareFusion 213 | Sterility | Nationwide |
| Drug | CLASS II | BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) recalledChloraprep One-step | CareFusion 213 | Sterility | Nationwide |
| Drug | CLASS II | BD ChloraPrep Hi-Lite Orange recalled by CareFusion 213Chloraprep One-step | CareFusion 213 | Sterility | Nationwide |
| Drug | CLASS II | BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate recalledChloraprep One-step | CareFusion 213 | Sterility | Nationwide |