Dosage form: intravenous infusion
Drug classes:Minerals and electrolytes, Miscellaneous respiratory agents
Medically reviewed by Drugs.com. Last updated on Mar 22, 2022.
IMPORTANT DRUG INFORMATION
March 2014
Subject: Temporary Importation of 0.9% Sodium Chloride Injection in VIAFLO (non-PVC) Containers
Dear Healthcare Professional,
Due to current critical shortage of 0.9% Sodium Chloride Injection in the U.S. market, Baxter Healthcare Corporation (Baxter) is coordinating with the Food and Drug Administration (FDA) to increase the availability of the drug. Baxter has initiated temporary importation of a foreign Sodium Chloride 0.9% Injection Solution for Intravenous Infusion in VIAFLO non-polyvinyl chloride (non-PVC) containers manufactured at Baxter’s Bieffe Medital, Sabinanigo, Spain facility and marketed within the European Union.
At this time, FDA is not objecting to the importation and distribution of Baxter’s Sodium Chloride 0.9% Injection Solution for Intravenous Infusion to address the critical shortage of Sodium Chloride 0.9% Injection. Importation or distribution of Baxter’s Sodium Chloride 0.9% Injection Solution for Intravenous Infusion by any entity other than Baxter is not within the scope of this decision and may be subject to enforcement action by the FDA. FDA has not approved this product in the United States.
Effective immediately, Baxter will offer the Sodium Chloride 0.9% Intravenous Infusion in VIAFLO (non-PVC) containers in the following volumes and quantities:
| Product | VIAFLO (non-PVC) Container |
| Sodium Chloride 0.9% Intravenous Infusion, 250 mL | 30 bags per carton |
| Sodium Chloride 0.9% Intraveno...
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