Bridgeport Hospital TPN Neonatal Standard Solution recalled over sterility concerns

Recall date

December 17, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Central Admixture Pharmacy Services, Inc. recalls Bridgeport Hospital (CT)TPN Neonatal Standard Solution, Trophamine 6% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/m…

Recall number

D-442-2015

FDA classification

Class I

Brand / firm

Central Admixture Pharmacy Services, Inc.

Sold / distributed

Nationwide

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Bridgeport Hospital (CT)TPN Neonatal Standard Solution, Trophamine 6% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, Calcium Gluconate 4mEq/L, compound vol: 150 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.