Hospira product recalled over sterility concerns
- Recall date
- July 2, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Hospira Inc. recalls 0.9% Sodium Chloride Injection USP, 50 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira, Inc., Ausitn, TX 78728, N…
- Recall number
- D-1240-2015
- FDA classification
- Class II
- Brand / firm
- Hospira Inc.
- Sold / distributed
- United States
Why it was recalled
Lack of assurance of sterility: Potential channel leaks near the threaded vial port.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
0.9% Sodium Chloride Injection USP, 50 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira, Inc., Ausitn, TX 78728, NDC 00409-7101-68
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