Public recall detail

Primene 10% Amino Acid Injection, 250 mL, Pharmacy Bulk Pack - Compatibility Issue with Trace Elements

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Recall Safety notice
Quick summary

Quick summary: Primene 10% Amino Acid Injection, 250 mL, Pharmacy Bulk Pack - Compatibility Issue with Trace Elements .

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Recall details

Quick summary: Primene 10% Amino Acid Injection, 250 mL, Pharmacy Bulk Pack - Compatibility Issue with Trace Elements .

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

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Issue

Primene 10% solution may not be compatible when compounded with trace elements. 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.

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