Lincare product recalled over sterility concerns

Recall date

May 28, 2015

Source

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

Official notice title

Lincare, Inc. recalls TPN 2:1, 200 ml Bags, Qty: 7, Base Formula NaCl 0.9%, Dextrose 70%, Trophamine 10%, Water for Inj; Electrolytes Calcium…

Recall number

D-1158-2015

FDA classification

Class II

Brand / firm

Lincare, Inc.

Sold / distributed

United States including: Arkansas

Why it was recalled

Lack of Assurance of Sterility: Sterility of product is not assured.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

TPN 2:1, 200 ml Bags, Qty: 7, Base Formula NaCl 0.9%, Dextrose 70%, Trophamine 10%, Water for Inj; Electrolytes Calcium Gluc, MgSO4, Na Phos, KCL; Vitamins, trace elements and medications Copper Cl, Selenium, Zinc Sulfate, Infuvite Pediat, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.