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 3:1, 1844 mL Bags, Qty: 6, Base Formula Sodium Chloride, Dextrose 70%, Clinisol SF 15%, Intralipid 20%, Water for I…

Recall number

D-1165-2015

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 3:1, 1844 mL Bags, Qty: 6, Base Formula Sodium Chloride, Dextrose 70%, Clinisol SF 15%, Intralipid 20%, Water for Inj; Electrolytes KCL, Ca Gluconate, MgSO4, K Phos; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.