FDADecember 17, 2014drug

Sinai Hospital (MD) TPN Neonatal Day 1 Bag, Trophamine 10 g, Dextrose 25 g, Additives: Calcium Gluconate 1500 mg, 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 insert; CAPS, Allentown, PA.

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

central admixture pharmacy servicescentralcentral admixture

Recall history

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

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Sinai Hospital (MD) TPN Neonatal Day 1 Bag, Trophamine 10 g, Dextrose 25 g, Additives: Calcium Gluconate 1500 mg, 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 insert; CAPS, Allentown, PA. — Recall Details · AllClear