Drug & medication recalls Moderate risk

5% Dextrose Injection recalled over sterility concerns

Recall date
May 31, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
ICU Medical Inc recalls 5% Dextrose Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7922-02
Recall number
D-0885-2018
FDA classification
Class II
Brand / firm
ICU Medical Inc
Sold / distributed
Nationwide and Canada

Why it was recalled

Lack of assurance of sterility: Bags have 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, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7922-02

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