The Recall Desk
SevereFDA (Drugs)·D-1152-2015·Announced 2015-07-08

Lincare Recalls TPN 3:1 Bags Due to Sterility Concerns

Lincare, Inc. is recalling TPN 3:1 bags compounded between May 14 and May 27, 2015, 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, and the hazard involves a lack of assurance of sterility for an intravenous product, which carries a significant risk of serious injury or hospitalization due to potential infection.

Plain-English summary

Lincare, Inc. is recalling TPN 3:1, 2400 mL bags (quantity of 6) that were compounded by United Medical IV Center in Little Rock, Arkansas. The recall covers all product compounded between May 14, 2015, and May 27, 2015. The product is a prescription-only total parenteral nutrition solution containing dextrose, Travasol, Intralipid, electrolytes, vitamins, and trace elements.

The recall was initiated because the sterility of the product is not assured. This lack of assurance of sterility poses a risk of infection to patients using the product. The recall is classified as FDA Class II.

The affected 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 instructions on how to return the product or obtain a replacement.

The recalled product

Product
TPN 3:1, 2400 mL Bag, Qty: 6, Base Formula Sodium Chloride, Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj.; Electrolytes KCL, K Acetate, Na Acetate, K Phos, MgSO4; Vitamins, trace elements and medications Trace Ele. -Ped, Multi Vitamin, Rx Only, Compounded by: United
Manufacturer
Lincare, Inc.
Category
Drug — IV Compounded
Hazard
Affected units
6

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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