Abington Memorial Hospital TPN Neonatal Starter 0 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 Abington Memorial Hospital (PA) TPN Neonatal Starter 0.4-0.599 Kg, Amino Acids, Neonate 3g, Dextrose 5%, 150 ml, Additi…

Recall number

D-462-2015

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

Abington Memorial Hospital (PA) TPN Neonatal Starter 0.4-0.599 Kg, Amino Acids, Neonate 3g, Dextrose 5%, 150 ml, Additives: heparin PF 75 units, Calcium Gluconate 300mg, 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.