Lincare Recalls Deferoxamine Mesylate IV Bags Due to Sterility Concerns
Lincare, Inc. is recalling Deferoxamine Mesylate IV bags compounded by United Medical IV Center because the sterility of the product is not assured.
What this means for you
Illness, injury, or structural failure has been reported. 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' rating under the rubric, particularly given the risk of infection from non-sterile IV products.
Plain-English summary
Lincare, Inc. is recalling Deferoxamine Mesylate 3gm / NS 240mL Accuflo, packaged in 240 mL bags, which is a prescription-only medication. The product was compounded by United Medical IV Center in Little Rock, Arkansas, on May 28, 2015, with a discard-after date of June 11, 2015.
The recall was initiated because the sterility of the product is not assured. This means there is a lack of assurance that the medication is free from microbial contamination.
The affected product was distributed in the United States, including Arkansas. Patients and healthcare providers should stop using the recalled product and contact their healthcare provider for further instructions.
The recalled product
- Product
- DEFEROXAMINE MESYLATE 3gm / NS 240mL Accuflo, Packaged in 240 mL Bags, 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
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 05/28/2015
- Discard After: 06/11/2015
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.
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