ChloraPrep Swabstick Topical Antiseptic Recalled Due to Sterility Assurance Issues
ChloraPrep Swabstick, an over-the-counter topical antiseptic, is being recalled due to lack of assurance of sterility. CareFusion 213, LLC initiated the recall affecting 106,400 units (lot #5086623) distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a sterile product with no reported illnesses or injuries. The hazard is a lack of sterility assurance, which represents a theoretical risk of contamination. This qualifies as a risk-of-harm product where injury has not yet been reported, placing it in the High (3) severity category per the rubric.
Plain-English summary
ChloraPrep Swabstick is an over-the-counter topical antiseptic manufactured by CareFusion 213, LLC. The product contains chlorhexidine gluconate 2% and isopropyl alcohol 70% in 5.25 mL applicators.
CareFusion 213, LLC initiated a recall due to lack of assurance of sterility. The recall affects lot number 5086623 with an expiration date of 03/31/2028, representing 106,400 units distributed nationwide.
The product is used for topical skin preparation prior to medical and surgical procedures. Consumers and healthcare providers in possession of affected lots should contact the manufacturer or their healthcare provider for guidance.
The recalled product
- Product
- CHLORAPREP SWABSTICK (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
- Brand
- CHLORAPREP SWABSTICK
- Manufacturer
- CareFusion 213, LLC
- Category
- Drug — Topical Antiseptic
- Hazard
- sterility
- contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 5086623
- Exp. Date 03/31/2028
Distribution
Distributed nationwide across the United States.
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