FDA Recall D-0649-2024

Baxter Healthcare Corporation · Round Lake, IL

Class I — life-threatening Ongoing 651 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

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

Lot / code: Lot # N008235, Exp 8/31/2024

Quantity: 44,208 containers

Reason for recall

Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.

Recall record

Recall number: D-0649-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2024-08-01
Classified by FDA Center: 2024-08-30
FDA published: 2024-09-11
Recalling firm: Baxter Healthcare Corporation
Firm location: Round Lake, IL

Drug identification

Brand name(s): HEPARIN SODIUM IN SODIUM CHLORIDE
Generic name(s): HEPARIN SODIUM
Manufacturer(s): Baxter Healthcare Corporation
NDC(s): 0338-0424, 0338-0431, 0338-0433, 0338-0428
Route(s): INTRAVENOUS

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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