Fluorouracil 4250mg / D5W recalled over sterility concerns
- Recall date
- May 28, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Lincare, Inc. recalls Fluorouracil 4250mg / D5W 285mL, Qty: 1 285 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527…
- Recall number
- D-1203-2015
- FDA classification
- Class II
- Brand / firm
- Lincare, Inc.
- Sold / distributed
- United States including: Arkansas
Why it was recalled
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Fluorouracil 4250mg / D5W 285mL, Qty: 1 285 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
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