The Recall Desk
SevereFDA (Drugs)·D-1174-2015·Announced 2015-07-08

Lincare Recalls Fluorouracil IV Bags Due to Sterility Concerns

Lincare, Inc. is recalling Fluorouracil 4800mg IV bags compounded in Arkansas 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 in an intravenous medication, which poses a significant risk of serious injury or infection.

Plain-English summary

Lincare, Inc. is recalling Fluorouracil 4800mg / D5W 296mL IV bags, prescription only, 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 was compounded on May 27, 2015, and has a discard after date of June 10, 2015. The distribution pattern includes the United States, specifically 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
Fluorouracil 4800mg / D5W 296mL, Qty: 1 296 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Manufacturer
Lincare, Inc.
Category
Drug — IV Infusion
Hazard
Affected units
1

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 (2)

  • Compounded on 05/27/15
  • Discard After: 06/10/15

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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