The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1187-2015·Announced 2015-07-08

Lincare Recalls Fentanyl Citrate IV Bags Due to Sterility Concerns

Lincare, Inc. is recalling Fentanyl Citrate 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. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant risks such as lack of sterility assurance in IV products.

Plain-English summary

Lincare, Inc. is recalling Fentanyl Citrate, FENTANYL 25,000 MCG / 500 ML, 500 mL bags. The product is compounded by United Medical IV Center in Little Rock, Arkansas, and was compounded on May 29, 2015, with a discard after date of June 26, 2015.

The recall was initiated because the sterility of the product is not assured. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The product was distributed in the United States, including Arkansas. Patients or healthcare providers who have received this specific product should contact their healthcare provider or Lincare, Inc. for further instructions on how to proceed.

The recalled product

Product
Fentanyl Citrate, FENTANYL 25,000 MCG / 500 ML, Qty: 1 500 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: 06/26/15

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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