MHRA Class 2 Medicines Recall: ChloraPrep 1mL Clear Sterile Solution/Applicator (Becton Dickinson UK Ltd)
MHRA Class 2 Medicines Recall: ChloraPrep 1mL Clear Sterile Solution/Applicator (Becton Dickinson UK Ltd)
Drug alert number: EL(25)A/36
Date issued: 28 July 2025
Becton Dickinson UK Ltd has informed the MHRA that some units exhibit an open seal on the packaging of the applicator. This is linked to the Class 2 Medicines Notification EL(25)A/22. This defect could increase the risk of the applicator device being contaminated with pathogens.
DMRC reference number: DMRC-35522050
Company name: Becton Dickinson UK Ltd
Medicine Details
Product name: ChloraPrep 1mL Clear Sterile Solution/Applicator
Product License: PL05920/0002
Active ingredient: chlorhexidine gluconate 2%w/v and isopropyl alcohol 70% v/v
SNOMED code: 40818011000001105
GTIN: 20885403491761
Affected Lot Batch Numbers:
| Batch No. | Expiry Date | Pack Size | First Distributed |
| 4255106 | 30/09/2027 | 60 | 10/03/2025 |
Background
Becton Dickinson UK Ltd has informed the MHRA that some units exhibit an open seal on the packaging of the applicator. This issue is linked to the previous Class 2 Medicines Notification EL(25)A/22. This defect could increase the risk of the applicator device being contaminated with pathogens, which could lead to increased infection rates for the patients.
The number of impacted units in the batch is unknown, therefore the batch in the table is being recalled as a precautionary measure. This recall does not impact other batches of BD ChloraPrep Clear – 1mL Applicator that remain available for clinical use.
Advice for Healthcare Professionals
Stop supplying the affected batches. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
View the full alert here.
Advice for Patients
No further action is required by patients as this product is used by healthcare professionals only and they will have taken the action to remove this product from use.
The recall is a precautionary measure to mitigate any additional risk of infection.
Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.
Additional information
For all medical information enquiries and information on this product, please email safetyinformation@bd.com, or telephone 08000437546.
For stock control enquiries please email info@insightbio.com, or telephone 01707351330.
