Becton Dickinson UK Ltd has issued a Class 2 medicines recall for specific batches of ChloraPrep antiseptic applicators due to potential sterility breaches during the packaging process, according to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). The recall affects ChloraPrep 2% 1mL and ChloraPrep Frepp 2% 1.5mL applicators used for pre-surgical skin preparation.
Key takeaways
- MHRA issued Class 2 recall for ChloraPrep antiseptic applicators due to packaging sterility breach
- Affected products include 2% chlorhexidine gluconate 1mL and 1.5mL applicators
- Healthcare facilities must immediately quarantine affected batches and return to supplier
Recall Details and Affected Products
The MHRA alert EL(26)A/26 specifies that the recall encompasses ChloraPrep 2% 1mL applicators and ChloraPrep Frepp 2% 1.5mL applicators where sterility may have been compromised during manufacturing. ChloraPrep contains 2% chlorhexidine gluconate and 70% isopropyl alcohol, commonly used for skin antisepsis before surgical procedures.
Becton Dickinson identified the potential sterility breach through internal quality monitoring processes. The company has notified all direct customers and is coordinating the recall through established pharmaceutical distribution channels, according to the MHRA drug and device alert system.
Healthcare Facility Response Requirements
Healthcare facilities must immediately identify and quarantine any affected ChloraPrep applicators in their inventory. The MHRA guidance requires facilities to check batch numbers against the recall notice and cease use of identified products immediately.
Facilities should contact their usual supplier for product return and replacement procedures. The Care Quality Commission emphasizes that proper antiseptic preparation remains critical for preventing surgical site infections, and facilities should ensure adequate alternative antiseptic supplies during the recall period.
Class 2 medicines recalls indicate there may be a risk to health, but the risk is not usually life-threatening and is often manageable with appropriate clinical oversight
— MHRA Classification System, UK Government Guidance
What this means
Frequently asked questions
What should healthcare facilities do with recalled ChloraPrep applicators?
Facilities must immediately quarantine affected products and contact their supplier for return procedures. Use alternative antiseptic preparations for surgical procedures until replacement stock arrives.
Are patients at risk from this recall?
The MHRA classifies this as Class 2, indicating manageable health risks with proper clinical oversight. Alternative antiseptic preparations ensure continued safe surgical care.
How can facilities identify affected products?
Check batch numbers on ChloraPrep 2% 1mL and ChloraPrep Frepp 2% 1.5mL applicators against the specific batches listed in MHRA alert EL(26)A/26.
The recall underscores the importance of robust pharmaceutical quality monitoring and rapid response systems in maintaining patient safety. Healthcare facilities maintaining diverse antiseptic supply chains can better manage such disruptions while ensuring continued infection prevention standards.
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