ChloraPrep 1mL 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 - 40102707
| Product | Licence | Active ingredient | GTIN |
|---|---|---|---|
| ChloraPrep 1mL Applicator | PL: 05920/0002 | Chlorhexidine gluconate 2%w/v and isopropyl alcohol 70% v/v | 20885403491761 |
Background: Becton Dickinson UK Ltd are recalling batches of ChloraPrep 2% w/v / 70% v/v cutaneous solution 1mL 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 05/2029. Batches with an expiry date after 05/2029 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. This recall is specific to the lots in included in Annex 1.