The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1175-2015·Announced 2015-07-08

Lincare Recalls Fluorouracil IV Bags Due to Sterility Concerns

Lincare, Inc. is recalling Fluorouracil 1200mg 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 source text identifies this as an FDA Class II recall. Per the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving potential hospitalization or significant injury risks associated with sterility failures in IV products.

Plain-English summary

Lincare, Inc. is recalling Fluorouracil 1200mg / D5W 274mL IV bags. These prescription-only products were compounded by United Medical IV Center in Little Rock, Arkansas, and distributed in the United States, including Arkansas. The specific lot was compounded on May 28, 2015, with a discard after date of June 11, 2015.

The recall was initiated due to a lack of assurance of sterility. The source text states that the sterility of the product is not assured. This is an FDA Class II recall, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.

Patients who have received this specific product should contact their healthcare provider for guidance. The recall is limited to the specific lot compounded on May 28, 2015, by United Medical IV Center.

The recalled product

Product
Fluorouracil 1200mg / D5W 274mL, Qty: 1 274 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 05/28/15
  • Discard After: 06/11/15

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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