ChloraPrep One-Step 2% w/v chlorhexidine gluconate recall: Sterility Concern
ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25…
Why was ChloraPrep One-Step 2% w/v chlorhexidine gluconate recalled?
Microbial Contamination of Non-Sterile Product: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
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?
All lots including but not limited to the following lot distributed in Zone IV: Lot # 0192894, Exp. 06/30/2023; 9080812 Exp 03/31/2022
- Product
- ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25…
- Recalling firm
- CareFusion 213, LLC
- Quantity
- 280 cartons
- Distribution
- Distributed in Puerto Rico and Oman
- Recall date
- March 3, 2021
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (drug)