ChloraPrep 1mL Clear Sterile Solution/Applicator
What this means
The MHRA has issued a medicines recall or defect notification. Class 1: risk to life, immediate recall. Class 2: may cause mistreatment or harm, recall within 48 hours. Class 3: unlikely to cause harm, recall within 5 days. Class 4 (defect notification): no recall, caution in use. The medicine remains licensed; only the listed batches are affected. Do not stop treatment without speaking to your doctor or pharmacist.
Class 2 recall · DMRC-35522050
| Product | Licence | Active ingredient | GTIN |
|---|---|---|---|
| ChloraPrep 1mL Clear Sterile Solution/Applicator | PL05920/0002 | chlorhexidine gluconate 2%w/v and isopropyl alcohol 70% v/v | 20885403491761 |
Batches (expiry): 4255106 (30/09/2027)
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