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ChloraPrep 2% w/v 70% v/v Cutaneous Solution, PA2287/001/002, Batch Recall, One batch

14/05/2025
Medicines for human use Recall

We wish to advise you that one batch of the medicine ChloraPrep 2% w/v 70% v/v Cutaneous Solution, PA2287/001/002 is being recalled by BD.

This recall is going to hospital level.

The medicine is being recalled because there is the potential for lack of applicator sterility due to breaches in the seal of the applicator packaging.

The recall letter, dated 13/05/2025, can be downloaded in the Documents section at the bottom of this webpage. 

Product information

Authorisation holder
Becton Dickinson France
Authorisation number
PA2287/001/002
Serial or batch number and expiry date
Batch no. 4116454, Expiry 04/2027
Human or veterinary medicine
Human
Target audience
Hospitals, Hospital pharmacies
Recall level
Hospital

Actions to be taken

Hospital pharmacists are requested to please take the following actions:

  1. Immediately identify and quarantine any units or partial packs of this batch which you have in your hospital. This includes stock on wards, at surgical units, in clinics and at any other relevant location within your hospital.
  2. Complete the Response Form (attached to the recall letter in the Documents section at the bottom of this webpage) and return it to the Iskus Health email contact noted on the form.
  3. If you have supplied units of this batch to any other pharmacy, clinic or other establishment, please forward a copy of the recall letter to them, and request they quarantine and return any units in their possession to you.

Please report any adverse reactions to BD at SafetyInformation@bd.com and to the HPRA at medsafety@hpra.ie.

Documents

Opens in new window ChloraPrep 2%_BatchRecall_13.05.2025 PDF : 356KB | 14/05/2025