FDAClass IIOctober 10, 2012

ChloraPrep One-Step recall: Sterility Concern

ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) Patient Preoperative Skin Preparation, 3mL Applicators, 25…

Why was ChloraPrep One-Step recalled?

Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot 52894, Product Code: 260400

Product
ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) Patient Preoperative Skin Preparation, 3mL Applicators, 25…
Recalling firm
Carefusion 213, Llc
Quantity
576 Cartons
Distribution
IL, MO, and NJ
Recall date
October 10, 2012
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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