Infosalus.- The AEMPS withdraws MediHoney products for wounds and burns due to packaging errors

MADRID, 20 (EUROPA PRESS)

The Spanish Agency for Medicines and Health Products (AEMPS) has reported the withdrawal of MediHoney wound and burn products, from the Canadian manufacturer Derma Sciences, due to packaging failures that could cause the loss of their sterility.

Among the failures identified were inadequate sealing of sterile barrier containers, failure to adequately protect the product in shipping boxes during transportation, and failure of the tube screw cap.

The affected items are Medihoney Wound Gel (references 391 and 395), Medihoney Medical Honey (reference 398), Medihoney Hydrogel (references 780, 781, 782 and 783), Medihoney Hcs Sterile Burn Dressing (references 784 and 785), Medihoney Hcs (reference 787) and Medihoney gel (reference 799).

These products are indicated for a wide range of acute and chronic wounds, donor and recipient graft sites, wounds with little or no exudation, leg or foot ulcers and pressure ulcers, general first aid and superficial and second degree burns, so these failures may pose a risk of infection to the patient.

Its distribution in Spain is carried out through the Madrid company PRIM, which has already sent a warning note to other distributors, health professionals, pharmacies and patients to inform them of the problem detected and the actions to follow.

Patients have been urged to stop using and discard these products if they have them, and have been advised to contact their healthcare professional if they need to continue treatment started with these products.

Healthcare professionals should inspect their inventory to identify if they have any of these products to quarantine. If you become aware that any patient is experiencing symptoms related to these failures, you must notify them through the NotificaPS portal.

For pharmacies, the recommendations consist of identifying if they have one of these products in their inventory, to separate them and quarantine them. After that, they must contact their distributor. If you are aware of any patient with symptoms related to these failures, you should follow the same procedure as healthcare professionals.

Distributors must also inspect their inventory and follow the same steps as healthcare professionals and pharmacies, which must be informed if any of these products have been delivered to them.