Back to RecallTracker
Health Canada Health products

Primene 10% Amino Acid Injection, 250 mL, Pharmacy Bulk Pack - Compatibility Issue with Trace Elements - Important Information Updates on All Lots

Issued April 21, 2015
Issue
There is potential for formation of a precipitate as a result of a suspected interaction between trace elements and cysteine. Formation of this precipitate may result in insufficient levels of cysteine and trace elements in TPN solutions. Deficiencies of cysteine or trace elements can lead to serious health consequences. Serious adverse effects are associated with the infusion of particulate matter. Infusion of a precipitate may lead to serious adverse effects including phlebitis, thrombophlebitis, thrombosis and major organ dysfunction.
Hazard description
Product safety