FDA recall D-1155-2015

Lincare, Inc. · Class II · drug

Product

TPN 3:1, 997 ml with lipids Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj; Electrolytes K Acetate, Na Acetate, KCL, Na Phos, Ca Gluconate, MgSO4, NaCl, Zinc Cl; Vitamins, trace elements and medications Selenium, Copper Cl, Carnitor, Rx Only. United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.

Reason for recall

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

Distribution

United States including: Arkansas

Key facts

Status: Terminated
Initiation date: 2015-05-28
Report date: 2015-07-08
Termination date: 2017-02-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Little Rock, AR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1155-2015