The Recall Desk
SevereFDA (Drugs)·D-1160-2015·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. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or in this case, a critical sterility failure in an IV product, align with a Severe rating (Score 4).

Plain-English summary

Lincare, Inc. is recalling TPN 3:1, 1440 mL bags (quantity of 7) that were compounded by United Medical IV Center in Little Rock, Arkansas. The affected products were compounded between May 14, 2015, and May 27, 2015. The recall was initiated because the sterility of the product is not assured.

The recalled product is a prescription-only total parenteral nutrition (TPN) solution containing dextrose, Travasol, Intralipid, sterile water, electrolytes, vitamins, trace elements, and folic acid. The distribution pattern includes the United States, specifically Arkansas.

Consumers and healthcare providers should stop using the affected TPN bags and contact Lincare, Inc. or their healthcare provider for instructions on how to return or dispose of the product.

The recalled product

Product
TPN 3:1, 1440 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Sterile Water; Electrolytes Calcium Gluc, Na Phos, Na Acetate, MgSO4, K Acetate; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Folic Acid, Rx Only. Compounded by: Unite
Manufacturer
Lincare, Inc.
Category
Drug — IV Therapy
Hazard
Affected units
7

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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