5% Dextrose Injection recalled over sterility concerns
- Recall date
- October 8, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- ICU Medical Inc recalls 5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC 0409-7922-02, Hospira, Inc. Lake Forest,…
- Recall number
- D-0215-2019
- FDA classification
- Class II
- Brand / firm
- ICU Medical Inc
- Sold / distributed
- Nationwide.
Why it was recalled
Lack of Assurance of Sterility; bags have the potential to leak
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC 0409-7922-02, Hospira, Inc. Lake Forest, IL 60045
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