Drug product
Heparin 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 0338-0431-03
D-1131-2015
Product summary
- Event
- Event 71356
- Status
- Terminated
- Classification
- Class II
- Quantity
- 145,350 containers
- Official record key
drug-enforcement:D-1131-2015
Official wording
Reason: Subpotent Drug; out of specification results for heparin raw material
Code information: Product Code: 280953 Lots: N002998 and N003004 exp 12/31/15; and lot N003038 exp. 01/31/2016
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent