Lincare Recalls Ciprofloxacin IV Bags Due to Sterility Concerns
Lincare, Inc. is recalling Ciprofloxacin 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 involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While no specific injuries are reported in the text, the lack of sterility assurance in an IV product poses a significant risk of serious harm, aligning with the Severe classification for Class II recalls with potential for significant injury.
Plain-English summary
Lincare, Inc. is recalling Ciprofloxacin 400mg / D5W 200ml Accuflo, packaged in 3 200 mL bags. The product is prescription-only and was 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 was compounded on May 28, 2015, and has a discard-after date of June 11, 2015. The recall covers distribution in 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
- CIPROFLOXACIN 400MG / D5W 200ML ACCUFLO, Packaged in 3 200 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
- Affected units
- 3
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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