Recall Enforment Report D-1336-2015

Recall Details

Multi event Drug Recall Enforcement Report Class I voluntary initiated by Baxter Healthcare Corp., originally initiated on 07-17-2015 for the product 0.9% Sodium Chloride Injection USP, 50 mL Single Dose VIAFLEX Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B1301, NDC 0338-0049-11. The product was recalled due to presence of particulate matter: customer complaint for an insect found free floating inside a single bag for each lot recalled.. 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-1336-201507-17-201508-26-2015Class I189,120 bags0.9% Sodium Chloride Injection USP, 50 mL Single Dose VIAFLEX Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B1301, NDC 0338-0049-11.Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.Terminated
D-1335-201507-17-201508-26-2015Class I133,600 bags0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553-18.Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.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
0338-0553Sodium Chloride Sodium ChlorideInjectionIntravenousBaxter Healthcare CorporationHuman Prescription Drug