FDA Recall Heparin Sodium In Sodium Chloride

View Recall Number, Date, Reasons, Quantity

FDA Recall Enforcement Reports

The last Recall Enforcement Report for Heparin Sodium In Sodium Chloride with NDC 0338-0433 was initiated on 06-03-2015 as a Class II recall due to subpotent drug; out of specification results for heparin raw material The latest recall number for this product is D-1131-2015 and the recall is currently terminated as of 03-14-2017 .

Recall Number Initiation Date Report Date Recall Classification Product Quantity Product Description Status
D-1131-201506-03-201506-17-2015Class II145,350 containersHeparin Sodium and 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- NDC 0338-0431-03Terminated
D-0276-201510-30-201412-03-2014Class II127,746 Viaflex Plus ContainerHeparin Sodium in 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx only, Manufactured for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015 by Baxter Healthcare Corporation 250 Road 144 Jayuya, Puerto Rico, 00664, NDC 0338-0431-03Terminated
D-626-201305-21-201307-10-2013Class IIHeparin 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 60015Terminated

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.