FDADecember 17, 2014drug

Holy Cross Hospital (MD) AA3%TPN Neonatal Day 1 Bag, Trophamine 10%/3% Dextrose 70%/10%, Additives: Calcium Gluconate 0.46 mEq/mL, 5mEq, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene ins...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Non-Sterility: Out of specification results for the sterility test for microbial contamination.

What to do

FDA enforcement status: Terminated

Brands named

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Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Holy Cross Hospital (MD) AA3%TPN Neonatal Day 1 Bag, Trophamine 10%/3% Dextrose 70%/10%, Additives: Calcium Gluconate 0.46 mEq/mL, 5mEq, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene ins... — Recall Details · AllClear