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Recall Observatory FDA recall evidence

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

June 03, 2015

Class II

Product summary

Firm
Baxter Healthcare Corp
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

    reason.potency_specification_failure · v1.0.0

    Subpotent