Public recall detail

Primene 10% Amino Acid Solution, 250 mL - Compatibility Issue with Trace Elements - Update

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Recall Safety notice
Quick summary

Quick summary: Primene 10% Amino Acid Solution, 250 mL - Compatibility Issue with Trace Elements - Update .

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Recall details

Quick summary: Primene 10% Amino Acid Solution, 250 mL - Compatibility Issue with Trace Elements - Update .

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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 may be 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.

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