RecallClass 2 · Action within 48 hours
Class 2 Medicines Recall: Becton Dickinson UK Ltd, ChloraPrep 2% 1mL and ChloraPrep Frepp 2% 1.5mL applicators, EL(26)A/26
Read and act on the official notice on GOV.UK
Class 2 recall — Action within 48 hours.
The MHRA uses Class 2 when:
The defect may cause mistreatment or harm to the patient, but it is not life-threatening or serious.
What all four recall classes mean
| Class | Action | The MHRA's definition |
|---|---|---|
| Class 1 | Immediate action | The defect presents a risk of death or disability. |
| Class 2 this recall | Action within 48 hours | The defect may cause mistreatment or harm to the patient, but it is not life-threatening or serious. |
| Class 3 | Action within 5 days | The defect is unlikely to cause harm to the patient. |
| Class 4 | Caution in use | Usually minor defects in packaging or other printed materials. |
A Class 1 recall usually comes with a National Patient Safety Alert. Source: MHRA, safety communications.
The MHRA's summary
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.
Affected batches
As listed by the MHRA, exactly as published. Always check against the GOV.UK notice before acting.
Not the full list. Further batches are listed in an annex to the notice — open the GOV.UK notice for every batch.
| Batch number | Expiry | Pack size | First distributed |
|---|---|---|---|
| ChloraPrep Frepp 2% w/v / 70% v/v cutaneous solution 1.5 mL applicators | |||
| 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 |
MHRA's audience tags: Dispensing GP practices, General practice, Pharmacy