Kaletra (lopinavir/ritonavir) oral solution, 2 bottle pack containing 2-ml oral dosing syringes: Presence of amide particles in 2-ml oral dosing syringes.

Summary of an identified quality defect

• Small visible particles/flakes were observed in empty 2-ml oral dosing syringes for use with Kaletra oral solution in November 2020.
• The material was identified as erucamide, which is classified and certified as a food additive and was assessed during a toxicology evaluation. These recommendations aim to remove these particles as complete as possible.
• The observed particles/flakes are loose in the syringes and could potentially be dispersed into the oral solution.
• The particles/flakes are too small to block the syringe and to cause physical injury or internal obstruction even if ingested by very small children.
• The risk of harm from ingesting the particles/flakes with the solution is negligible, therefore the product is safe to use by oral administration.
• This quality defect only concerns the 2-ml oral dosing syringes; the quality and safety of Kaletra oral solution itself are not affected.
• AbbVie recommends washing the syringe before the first use. The information in the package leaflet and the boxed instructions below recommend washing after each use. The same instruction should be followed to wash the syringe before the first use.

It is important to let the syringe dry completely before you use that syringe for dosing.