Recall Enforment Report D-0958-2016

Recall Details

Multi event Drug Recall Enforcement Report Class I voluntary initiated by Baxter Healthcare Corp., originally initiated on 12-15-2015 for the product Dextrose Injection,USP,70% 2000 mL VIAFLEX Plastic Container Bag, Pharmacy Bulk Package, Not For Direct Infusion, Must Be Diluted, Rx Only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0719-06 The product was recalled due to presence of particulate matter: confirmed customer compliants of finding an insect floating in the primary container of each product.. 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-0958-201612-15-201506-15-2016Class I28,080 VIAFLEX Plastic ContainersDextrose Injection,USP,70% 2000 mL VIAFLEX Plastic Container Bag, Pharmacy Bulk Package, Not For Direct Infusion, Must Be Diluted, Rx Only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0719-06Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.Terminated
D-0957-201612-15-201506-15-2016Class I255,852 VIAFLEX Plastic Containers0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container Bag, Rx Only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0049-02Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.Terminated

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
0338-0043Sodium Chloride Sodium ChlorideInjection, SolutionIntravenousBaxter Healthcare CorporationHuman Prescription Drug
0338-0049Sodium Chloride Sodium ChlorideInjection, SolutionIntravenousBaxter Healthcare CorporationHuman Prescription Drug
0338-0719Dextrose Baxter Healthcare Corporation
0338-0719Dextrose Dextrose MonohydrateInjection, SolutionIntravenousBaxter Healthcare CorporationHuman Prescription Drug