RegulatorsMHRAUnited Kingdom
MHRA Class 2 Recall: ChloraPrep 2% applicators (potential sterility breach)
Regulatory action
Class 2 Medicines Recall
ChloraPrep 2% 1mL applicator · Becton Dickinson UK Ltd
Relevant for
Regulatory Intelligence LeadSignal Management Lead
Action needed
Identify and quarantine all impacted batches of ChloraPrep 2% 1mL and Frepp 2% 1.5mL applicators; return to Becton Dickinson UK Ltd.
Process impact
Signal ManagementLabeling
SOP impact
2 SOPs may need review
Urgency: HighConfidence: high
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