CLASS II Drug recall · Reported 17 Jun 2015 · FDA Enforcement Report

Heparin Sodium and 0.9% Sodium Chloride Injection recalled

Baxter Healthcare is recalling Heparin Sodium and 0.9% Sodium Chloride Injection, 1000 USP Heparin Units in a Viaflex, distributed nationwide in the US. The recall was initiated on 3 Jun 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code: 280953 Lots: N002998 and N003004 exp 12/31/15; and lot N003038 exp. 01/31/2016

NDC0338-0424, 0338-0431, 0338-0433, 0338-0428

Quantity recalled145,350 containers

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1131-2015
FDA event ID: 71356
Recalling firm: Baxter Healthcare, Deerfield, IL
Brand: Heparin Sodium In Sodium Chloride
Manufacturer: Baxter Healthcare Corporation
Classification: Class II
Status: Terminated
Recall initiated: 3 Jun 2015
FDA classified: 9 Jun 2015
Reported: 17 Jun 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Blood Thinners

Timeline

3 Jun 2015	Recall initiated by company
9 Jun 2015	Classified by FDA	+6 days
17 Jun 2015	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Subpotent Drug; out of specification results for heparin raw material

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Subpotent Drug; out of specification results for heparin raw material

Which lots are affected?

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

Where was it sold?

Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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16 Sep 2026Drug	CLASS I	Dextrose Injection, USP, 70 % recalled by Baxter Healthcare	Baxter Healthcare	Particulate Matter	Nationwide
9 Sep 2026Drug	CLASS I	0.9% Sodium Chloride Injection USP, Viaflex recalledSodium Chloride	Baxter Healthcare	Particulate Matter	IL
9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
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Other Heparin recalls

All 22

Reported	Class	Recall	Company	Reason	Where
11 Sep 2024Drug	CLASS I	Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection) recalledHeparin Sodium In Sodium Chloride	Baxter Healthcare	Sterility	Nationwide
24 May 2023Drug	CLASS II	Heparin Sodium, 25,000 USP units recalled by B. Braun MedicalHeparin Sodium In Dextrose	B. Braun Medical	Potency & Assay	Nationwide
15 Mar 2023Drug	CLASS II	Heparin Sodium Injection, USP, 20,000 USP units per mL recalledHeparin Sodium	Sagent Pharmaceuticals	Other	Nationwide
15 Mar 2023Drug	CLASS II	Heparin Sodium, 25,000USP units recalled by B. Braun MedicalHeparin Sodium In Dextrose	B. Braun Medical	Potency & Assay	Nationwide
1 Feb 2023Drug	CLASS II	Heparin/lido HCL/sodium Bicarb 100u/2mg/16.8mg/ML Syringe) recalled	Pharmacy Innovations	Sterility	Nationwide