June 2015 FDA Recall Heparin Sodium In Sodium Chloride by Baxter Healthcare Corp
D-1131-2015 - Subpotent Drug; out of specification results for heparin raw material

This Class II drug recall was voluntarily initiated by Baxter Healthcare Corp on June 3, 2015 for the product Heparin Sodium In Sodium Chloride. The FDA reported the reason for recall as subpotent drug; out of specification results for heparin raw material. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1131-2015

Reason for Recall
Subpotent Drug; out of specification results for heparin raw material
Initiated
06-03-2015
Reported
06-17-2015
Quantity
145,350 containers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71356
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Baxter Healthcare Corp
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-14-2017
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Product Code: 280953 Lots: N002998 and N003004 exp 12/31/15; and lot N003038 exp. 01/31/2016

Affected Packages Involved in this Recall

0338-0431-03 Heparin Sodium In Sodium Chloride
0338-0433-04 Heparin Sodium In Sodium Chloride
0338-0424-18 Heparin Sodium In Sodium Chloride
0338-0428-12 Heparin Sodium In Sodium Chloride