The Recall Desk
SevereFDA (Drugs)·D-1162-2015·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 recall is classified as FDA Class II, which corresponds to a Severe severity score according to the rubric.

Plain-English summary

Lincare, Inc. is recalling TPN 3:1, 817 mL bags (quantity of 5) 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 Dextrose 70%, Trophamine 10%, and Intralipid 20%, along with electrolytes, vitamins, trace elements, and medications. All product compounded between May 14, 2015, and May 27, 2015, is included in this recall.

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

The recalled product

Product
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
Manufacturer
Lincare, Inc.
Category
Drug — Total Parenteral Nutrition
Hazard
Affected units
5

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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