Drug & medication recalls Moderate risk

Baxter Healthcare product recalled over manufacturing violations

Recall date
August 21, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Baxter Healthcare Corporation recalls 0.9% Sodium Chloride Injection USP 100 mL bags, Rx only, Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 033…
Recall number
D-1128-2018
FDA classification
Class II
Brand / firm
Baxter Healthcare Corporation
Sold / distributed
TX and MS only

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 100 mL bags, Rx only, Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 0338-0049-18

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