Drug recall D-626-2013
Product
Heparin Sodium and 0.9% Sodium Chloride Injection, a) Product code 2B0944, 2000 USP Units, Viaflex Plus Container, 1000mL, (NDC 0338-0433-04), b) Product code 2B0953: 1000 USP Units, Viaflex Plus Container, 500 mL (NDC 0338-0431-03), Baxter, Deerfield, IL 60015
Reason for recall
Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
Lots and codes
Lot #: a) Product code 2B0944: N001164, Exp 7/13; b) Product code 2B0953: N001396, Exp 11/13
Recall details
- Recalling firm
- Baxter Healthcare Corp., Deerfield, IL
- Quantity
- N/A
- Distribution
- Nationwide & Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- May 21, 2013
- Terminated
- June 18, 2015
Related products
- Heparin Sodium in Sodium Chloride – drug information
- NDC 0338-0428 Heparin Sodium In Sodium Chloride · Heparin Sodium 200 [USP'U]/100mL · Baxter Healthcare Corporation
- NDC 0338-0431 Heparin Sodium In Sodium Chloride · Heparin Sodium 200 [USP'U]/100mL · Baxter Healthcare Corporation
- NDC 0338-0424 Heparin Sodium In Sodium Chloride · Heparin Sodium 200 [USP'U]/100mL · Baxter Healthcare Corporation
- NDC 0338-0433 Heparin Sodium In Sodium Chloride · Heparin Sodium 200 [USP'U]/100mL · Baxter Healthcare Corporation