The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1176-2015·Announced 2015-07-08

Lincare Recalls Fluorouracil Bags Due to Sterility Concerns

Lincare, Inc. is recalling specific Fluorouracil IV bags 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. According to the rubric, FDA Class II recalls with potential for serious injury or hospitalization (implied by sterility failure in IV products) map to a Severe (4) rating.

Plain-English summary

Lincare, Inc. is recalling Fluorouracil 1560mg / D5W 281mL bags. The recall is due to a lack of assurance of sterility, meaning the sterility of the product is not assured.

The affected product is a prescription-only IV bag compounded by United Medical IV Center in Little Rock, Arkansas. The specific bags were compounded on May 26, 2015, and have a discard after date of June 9, 2015. Distribution was limited to the United States, including 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 1560MG / D5W 281ML, Qty: 1 281 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 05/26/15
  • Discard After: 06/09/15

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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