The manufacturer detected metal particles originating from the mold used for 100 ml polypropylene bottles, causing contamination of the solution for injection and adherent/deposited solid particles in the bottles. The defect was assessed as posing a high risk to patients' health and life. Potential effects: parenteral complications, particle embolism, severe reactions, life-threatening events.
Download the app and stay informed
Get instant notifications about recalled products and protect your family.
FAQ