CLASS II Drug recall · Reported 3 Dec 2014 · FDA Enforcement Report
Heparin Sodium in 0.9% Sodium Chloride Injection recalled
Baxter Healthcare is recalling Heparin Sodium in 0.9% Sodium Chloride Injection, 1000 USP Heparin Units in a Viaflex, distributed nationwide in the US. The recall was initiated on 30 Oct 2014 and the FDA has classified it as Class II.
Check your package
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-0276-2015
- FDA event ID
- 69634
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Manufacturer
- Baxter Healthcare Corporation
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Oct 2014
- FDA classified
- 24 Nov 2014
- Reported
- 3 Dec 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Thinners
Timeline
| 30 Oct 2014 | Recall initiated by company | |
| 24 Nov 2014 | Classified by FDA | +25 days |
| 3 Dec 2014 | Published in enforcement report | +9 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: Heparin raw material was found to have low potency
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 in 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx only, Manufactured for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015 by Baxter Healthcare Corporation 250 Road 144 Jayuya, Puerto Rico, 00664, NDC 0338-0431-03
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Subpotent Drug: Heparin raw material was found to have low potency
Which lots are affected?
Lot #: N003061; N003079; and N003087, Exp 2/29/2016
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.
More recalls from Baxter Healthcare
All 573| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Dextrose Injection, USP, 70 % recalled by Baxter Healthcare | Baxter Healthcare | Particulate Matter | Nationwide |
| Drug | CLASS I | 0.9% Sodium Chloride Injection USP, Viaflex recalledSodium Chloride | Baxter Healthcare | Particulate Matter | IL |
| Device | CLASS II | Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Drug | CLASS II | Clindamycin Phosphate in 0.9% Sodium Chloride Injection recalledClindamycin Phosphate | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
Other Heparin recalls
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection) recalledHeparin Sodium In Sodium Chloride | Baxter Healthcare | Sterility | Nationwide |
| Drug | CLASS II | Heparin Sodium, 25,000 USP units recalled by B. Braun MedicalHeparin Sodium In Dextrose | B. Braun Medical | Potency & Assay | Nationwide |
| Drug | CLASS II | Heparin Sodium Injection, USP, 20,000 USP units per mL recalledHeparin Sodium | Sagent Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Heparin Sodium, 25,000USP units recalled by B. Braun MedicalHeparin Sodium In Dextrose | B. Braun Medical | Potency & Assay | Nationwide |
| Drug | CLASS II | Heparin/lido HCL/sodium Bicarb 100u/2mg/16.8mg/ML Syringe) recalled | Pharmacy Innovations | Sterility | Nationwide |