The Recall Desk
SevereFDA (Drugs)·D-1157-2015·Announced 2015-07-08

Lincare Recalls TPN 3:1 Bags Due to Sterility Concerns

Lincare, Inc. is recalling TPN 3:1 bags compounded by United Medical IV Center because the sterility of the product is not assured.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II. According to the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving critical products like TPN where sterility is a primary safety concern.

Plain-English summary

Lincare, Inc. is recalling TPN 3:1, 1800 ml Bags (Qty: 2) compounded by United Medical IV Center in Little Rock, Arkansas. The recall is due to a lack of assurance of sterility, meaning the sterility of the product is not assured.

The affected product includes a base formula of NaCl 0.9%, Dextrose 70%, Travasol 10%, Intralipid 20%, and Water, along with electrolytes (K Phos, Mag Sulfate, KCL, Ca Gluconate) and vitamins/trace elements (Multitrace-4, Multi Vitamin). The product is prescription-only. The recall covers all product compounded between May 14, 2015, and May 27, 2015.

The product was distributed in the United States, including Arkansas. Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or Lincare, Inc. for further instructions.

The recalled product

Product
TPN 3:1, 1800 ml Bags, Qty: 2, Base Formula NaCl 0.9%, Dextrose 70%, Travasol 10%, Intralipid 20%, Water; Electrolytes K Phos, Mag Sulfate, KCL, Ca Gluconate; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Rx Only. Compounded by: United Medical IV Center (
Manufacturer
Lincare, Inc.
Category
Drug — Total Parenteral Nutrition (TPN)
Hazard
Affected units
2

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • All product compounded between May 14
  • 2015 and May 27
  • 2015

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 54 recalled by Lincare, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 54 products in this recall →

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