Drug & medication recalls Moderate risk

Baxter Healthcare product recalled over sterility concerns

Recall date
July 18, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Baxter Healthcare Corporation recalls 0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 600…
Recall number
D-1514-2019
FDA classification
Class II
Brand / firm
Baxter Healthcare Corporation
Sold / distributed
Nationwide in the United States and Puerto Rico.

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

0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38.

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