Recall Enforment Report D-1210-2015

Recall Details

Multi event Drug Recall Enforcement Report Class I voluntary initiated by Baxter Healthcare Corp., originally initiated on 03-24-2015 for the product 10% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0023-02 The product was recalled due to presence of particulate matter: products recalled due to presence of particulate matter (metal). The product was distributed in Us, Puerto Rico, And Bermuda 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-1210-201503-24-201507-15-2015Class I18,324 bags10% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0023-02Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)Terminated
D-1208-201503-24-201507-15-2015Class I202,824 Bags0.9% Sodium Chloride Injection, USP, in 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0049-02Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)Terminated
D-1209-201503-24-201507-15-2015Class I402,284 bags5% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0017-02Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)Terminated
D-1211-201503-24-201507-15-2015Class I58,932 bagsLactated Ringers Injection, USP, 250mL VIAFELX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0117-02Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)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
0338-0117Lactated Ringers Sodium Chloride, Potassium Chloride, Sodium Lactate And Calcium ChlorideInjection, SolutionIntravenousBaxter Healthcare CompanyHuman Prescription Drug