Recall Enforment Report D-0973-2017

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Baxter Healthcare Corporation, originally initiated on 07-06-2017 for the product 0.9% Sodium Chloride Injection, USP, 100 mL VIAFLEX Container, Rx Only, Baxter Healthcare Corporation, Deerfield IL 60015 USA, Product Code: 2B1309, NDC: 0338-0049-38 The product was recalled due to lack of assurance of sterility: bags have the potential to leak.. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0973-201707-06-201707-19-2017Class II295,200 bags0.9% Sodium Chloride Injection, USP, 100 mL VIAFLEX Container, Rx Only, Baxter Healthcare Corporation, Deerfield IL 60015 USA, Product Code: 2B1309, NDC: 0338-0049-38Lack of Assurance of Sterility: Bags have the potential to leak.Terminated
D-0972-201707-06-201707-19-2017Class II54,528 bags5% Dextrose Injection, USP, 100 mL VIAFLEX Plastic Container, Rx only, Baxter Healthcare Corporation, Deerfield IL 60015 USA, Product Code: 2B0089, NDC: 0338-0017-38Lack of Assurance of Sterility: Bags have the potential to leak.Terminated

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
0338-0017Dextrose Dextrose MonohydrateInjection, SolutionIntravenousBaxter Healthcare CorporationHuman Prescription Drug
0338-0023Dextrose Baxter Healthcare Corporation
0338-0023Dextrose Dextrose MonohydrateInjection, SolutionIntravenousBaxter Healthcare CorporationHuman Prescription Drug
0338-0043Sodium Chloride Sodium ChlorideInjection, SolutionIntravenousBaxter Healthcare CorporationHuman Prescription Drug
0338-0049Sodium Chloride Sodium ChlorideInjection, SolutionIntravenousBaxter Healthcare CorporationHuman Prescription Drug