MHRA Class 2 Medicines Recall: ChloraPrep 2% 1mL and ChloraPrep Frepp 2% 1.5mL applicators (Becton Dickinson UK Ltd)

MHRA Class 2 Medicines Recall: ChloraPrep 2% 1mL and ChloraPrep Frepp 2% 1.5mL applicators (Becton Dickinson UK Ltd)

Drug alert number: EL(26)A/26

Date issued: 2 June 2026

Becton Dickinson UK Ltd are recalling batches of ChloraPrep 2% 1mL applicators and ChloraPrep Frepp 2% 1.5 mL applicators due to a potential breach of sterility in the packaging process.

DMRC reference number: DMRC-39617055

Company name: Becton Dickinson UK Ltd

Medicine Details

ChloraPrep 2% w/v / 70% v/v cutaneous solution 1mL applicators (PL: 05920/0002)

Active Ingredient: chlorhexidine gluconate 2%w/v and isopropyl alcohol 70% v/v

SNOMED code: 40818111000001106

GTIN: 20885403491761  10885403491764

ChloraPrep Frepp 2% w/v / 70% v/v cutaneous solution 1.5 mL applicators (PL: 05920/0002)

Active Ingredient: chlorhexidine gluconate 2%w/v and isopropyl alcohol 70% v/v

SNOMED code: 12775311000001103

GTIN: 27613203022099

Affected Lot Batch Numbers:

Batch No. Expiry Date Pack Size First Distributed
All lots with an expiry date up to and including 02/2028 * All lots with an expiry date up to and including 02/2028 ChloraPrep 1mL Applicator: 60 applicators 11/09/2023
All lots with an expiry date up to and including 01/2028 * All lots with an expiry date up to and including 01/2028 ChloraPrep Frepp™ 1.5 ml Applicators: 20 applicators 09/01/2024

* For a full list of impacted batches, see Annex 1

Background

Becton Dickinson UK Ltd are recalling batches of ChloraPrep 2% w/v / 70% v/v cutaneous solution 1mL applicators and ChloraPrep Frepp 2% w/v / 70% v/v cutaneous solution 1.5 mL applicators due to a potential breach of sterility in the packaging process. The recall applies to all batches with an expiry date up to and including 02/2028. Batches with an expiry date after 02/2028 are not impacted.

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 each batch is unknown, therefore the batches included in Annex 1 are being recalled as a precautionary measure.

The full list of impacted batch details is included in Annex 1.

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 alert here.

Advice for Healthcare Professionals to Provide to 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.

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