Walter Reed Natl Mil Med Ctr Stock TPN D10% with Ca 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 Walter Reed Natl Mil Med Ctr (MD) Stock TPN D10% with Ca, Trophamine 12g, Dextrose 20g, Additives: Calcium Gluconate 8m…

Recall number

D-452-2015

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

Walter Reed Natl Mil Med Ctr (MD) Stock TPN D10% with Ca, Trophamine 12g, Dextrose 20g, Additives: Calcium Gluconate 8mEq, compound vol: 200 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.