Drug product
Heparin 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 0338-0431-03
D-0276-2015
Product summary
- Event
- Event 69634
- Status
- Terminated
- Classification
- Class II
- Quantity
- 127,746 Viaflex Plus Container
- Official record key
drug-enforcement:D-0276-2015
Official wording
Reason: Subpotent Drug: Heparin raw material was found to have low potency
Code information: Lot #: N003061; N003079; and N003087, Exp 2/29/2016
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent