The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1168-2015·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, which corresponds to a Severe severity score per the rubric, as it involves a potential risk of temporary or medically reversible health consequences.

Plain-English summary

Lincare, Inc. is recalling Fluorouracil 5760mg / D5W 265mL bags that were 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 is a prescription-only IV bag compounded on May 27, 2015, with 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 Lincare, Inc. or their healthcare provider for further instructions.

The recalled product

Product
Fluorouracil 5760mg / D5W 265mL Qty: 1 265 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.
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 05/27/15
  • 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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