August 2024 FDA Recall Heparin Sodium In Sodium Chloride by Baxter Healthcare Corporation
D-0649-2024 - Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.

This Class I drug recall was voluntarily initiated by Baxter Healthcare Corporation on August 1, 2024 for the product Heparin Sodium In Sodium Chloride. The FDA reported the reason for recall as microbial contamination of sterile products; out of limit results obtained for endotoxin testing.. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0649-2024

Reason for Recall
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Initiated
08-01-2024
Reported
09-11-2024
Quantity
44,208 containers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95102
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Baxter Healthcare Corporation
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 in the USA
Product Description About Product Description
Full technical description of the product.
Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Sterile Single Dose Container, Rx Only, Baxter USA, NDC 0338-0433-04

Batch or Lot Expiration Information

Lot# N008235, Exp 8/31/2024

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