PlainRecalls
FDA Drug Moderate Class II Terminated

TPN 3:1, 817 mL Bags, Qty: 5, Base Formula Dextrose 70%, Trophamine 10%, Intralipid 20%, Water for Inj; Electrolytes K Phos, KCL, MgSO4, NaCl, Ca Gluconate; Vitamins, trace elements and medications Trace Ele.-Ped, Infuvite Pediat, Carnitor, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.

Reported: July 8, 2015 Initiated: May 28, 2015 #D-1162-2015

Product Description

TPN 3:1, 817 mL Bags, Qty: 5, Base Formula Dextrose 70%, Trophamine 10%, Intralipid 20%, Water for Inj; Electrolytes K Phos, KCL, MgSO4, NaCl, Ca Gluconate; Vitamins, trace elements and medications Trace Ele.-Ped, Infuvite Pediat, Carnitor, Rx Only. Compounded by: 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.

Details

Recalling Firm
Lincare, Inc.
Units Affected
5 Bags
Distribution
United States including: Arkansas
Location
Little Rock, AR

Frequently Asked Questions

What product was recalled?
TPN 3:1, 817 mL Bags, Qty: 5, Base Formula Dextrose 70%, Trophamine 10%, Intralipid 20%, Water for Inj; Electrolytes K Phos, KCL, MgSO4, NaCl, Ca Gluconate; Vitamins, trace elements and medications Trace Ele.-Ped, Infuvite Pediat, Carnitor, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.. Recalled by Lincare, Inc.. Units affected: 5 Bags.
Why was this product recalled?
Lack of Assurance of Sterility: Sterility of product is not assured.
Which agency issued this recall?
This recall was issued by the FDA Drug on July 8, 2015. Severity: Moderate. Recall number: D-1162-2015.