Drug & medication recalls Moderate risk

ICU Medical product recalled over manufacturing violations

Recall date
February 4, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
ICU Medical Inc recalls 0.9% Sodium Chloride Injection, USP 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC…
Recall number
D-0509-2019
FDA classification
Class II
Brand / firm
ICU Medical Inc
Sold / distributed
Nationwide within the United States

Why it was recalled

CGMP Deviations

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 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-09

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