Multi event Drug Recall Enforcement Report Class I voluntary initiated by Baxter Healthcare Corp., originally initiated on 07-11-2014 for the product 0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX Container bags, NDC 0338-0049-41, Product Code 2B1306; and b) 100 mL VIAFLEX Container bags, NDC 0338-0049-18, Product Code 2B1302, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. The product was recalled due to presence of particulate matter: particulate matter identified as fibers and/or plastics.. 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-1591-2014 | 07-11-2014 | 09-24-2014 | Class I | a) 217,536 bags; b) 161,760 bags | 0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX Container bags, NDC 0338-0049-41, Product Code 2B1306; and b) 100 mL VIAFLEX Container bags, NDC 0338-0049-18, Product Code 2B1302, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. | Presence of Particulate Matter: particulate matter identified as fibers and/or plastics. | Terminated |
| D-1593-2014 | 07-11-2014 | 09-24-2014 | Class I | 171,672 bags | Potassium Chloride Injection, 20 mEq per 50 mL, 50 mL Sterile Single Dose Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0703-41, Product Code 2B0822. | Presence of Particulate Matter: particulate matter identified as fibers and/or plastics | Terminated |
| D-1592-2014 | 07-11-2014 | 09-24-2014 | Class I | 390,560 bags | 0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0553-18, Product Code 2B0043. | Presence of Particulate Matter: particulate matter identified as fibers and/or plastics. | Terminated |
Recalled Products
