ChlroraPrep One-Step recall: Sterility Concern
ChlroraPrep One-Step (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL Applicator - Clear, CareFusion El Paso, TX 79912…
Why was ChlroraPrep One-Step recalled?
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
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 #: 7240735, Exp. Date 08/09/2020; 7235540, Exp. Date. 08/06/2020; 7297579, Exp. Date 10/08/2020; 8003727, Exp. Date 11/29/2020; 8011688, 8012808, Exp.. Date 12/18/2020; 8095620, 8087784, 8095620, Exp. Date 03/31/2021; 8106737, 8130509, Exp. Date 04/30/2021; 8165721, 8187644, Exp. Date 06/30/2021; 8205560, Exp. Date 07/31/2021; 8247508, Exp. Date 08/31/2021; 8289654, Exp. Date 09/30/2021; 8155991, Exp. Date 05/31/2021; 8304783, Exp. Date 10/31/2021; 8337646, 8332585, 8338794, Exp. Date 11/30/2021; 9007921, 9015917, 9015920, Exp. date 12/31/2021; 9030934, 9045819, Exp. Date 01/31/2022; 9052554, 9059817, 9046572, 9071761, Exp. Date 02/28/2022; 9087982, 9087980, 9100768, 9101529, 9092575, 9105675, Exp. Date 03/31/2022; 9113528, 9123753, 9133928, Exp. Date 04/30/2022; 9135816, 9165856, Exp. Date 05/31/2022; 9199815, 9166196, 9198900, 9199815, 9194257, 9200420, Exp. Date 06/30/2022; 9205441, Exp. Date 07/31/2022; 9233323, 9233645, 9241929, 9238871, 9253785, Exp. Date 08/31/2022; 9261886, 9278673, 9266348, 9289666, Exp. Date 09/30/2022; 9293445, 9291336, 9297772, 9311057, 9305777, Exp. Date 10/31/2022; 9326162, 9344775, 9345956, Exp. Date 11/30/2022; 9352330, 0008777, 0016325, Exp. Date 12/31/2022; 0021072, 0030959, Exp. Date 01/31/2023, 0104864, Exp. Date 03/31/2023.
- Product
- ChlroraPrep One-Step (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL Applicator - Clear, CareFusion El Paso, TX 79912…
- Recalling firm
- CareFusion 213, LLC
- Quantity
- 4,272,300 applicators
- Distribution
- Puerto Rico, Guam, United Arab Emirates, Bahrain, Brazil, Democratic Republic of the Congo, Chile, Colombia, United Kingdom of Great Britain and Northern Ireland, Hong Kong, Israel, Kuwait, Oman, Qatar, Saudi Arabia, Singapore,
- Recall date
- August 26, 2020
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (drug)