Multi event Drug Recall Enforcement Report Class II voluntary initiated by Baxter Healthcare Corp., originally initiated on 03-18-2015 for the product 5% Dextrose Injection, USP, 1000mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0017-04 The product was recalled due to lack of assurance of sterility. complaints were receive of missing closures and/or leaks which may compromise product sterility.. 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-0426-2015 | 03-18-2015 | 04-01-2015 | Class II | 48,874 | 5% Dextrose Injection, USP, 1000mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0017-04 | Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility. | Terminated |
| D-0425-2015 | 03-18-2015 | 04-01-2015 | Class II | 597,498 units total | 0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0049-03 | Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility. | Terminated |
Recalled Products
