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D-1131-2015 Class II Terminated

Recalled by Baxter Healthcare Corp — Deerfield, IL

FDA drug recall D-1131-2015 was initiated by Baxter Healthcare Corp on Jun 3, 2015 and is designated Class II. Reason for recall: Subpotent Drug; out of specification results for heparin raw material The recall status is terminated (terminated Mar 14, 2017). Affected quantity: 145,350 containers.

Recall Details

Product Type: Drugs
Report Date: Jun 17, 2015
Initiation Date: Jun 3, 2015
Termination Date: Mar 14, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 145,350 containers

Product Description

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

Reason for Recall

Subpotent Drug; out of specification results for heparin raw material

Distribution Pattern

Nationwide

Code Information

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

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1131-2015
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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