The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1170-2015·Announced 2015-07-08

Lincare Recalls Fluorouracil IV Bags Due to Sterility Concerns

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

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 involves a lack of assurance of sterility in an intravenous medication, which poses a significant risk of serious injury or hospitalization if contaminated.

Plain-English summary

Lincare, Inc. is recalling Fluorouracil 1400mg / D5W 278mL IV bags. The product was compounded by United Medical IV Center in Little Rock, Arkansas, and distributed in the United States, including Arkansas. The recall was initiated because the sterility of the product is not assured.

The affected product is a prescription-only medication compounded on May 29, 2015, with a discard-after date of June 12, 2015. The recall is classified as Class II by the U.S. Food and Drug Administration.

Patients who have received this specific product should contact their healthcare provider for further instructions. Consumers should not use the product if they have not yet administered it and should follow the guidance of their medical team regarding the recall.

The recalled product

Product
Fluorouracil 1400mg / D5W 278mL Qty: 1 278 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 Compounded
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 05/29/15
  • Discard After: 06/12/15

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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