CLASS I Drug recall · Reported 31 Dec 2014 · FDA Enforcement Report
Heparin Sodium, 1000 USP Heparin Units recalled by Hospira
Hospira is recalling Heparin Sodium, 1000 USP Heparin Units/ (2 USP Heparin Units/mL), in 0.9% Sodium Chloride, distributed nationwide in the US. The recall was initiated on 11 Sep 2014 and the FDA has classified it as Class I.
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-0324-2015
- FDA event ID
- 69214
- Recalling firm
- Hospira, Lake Forest, IL
- Brand
- Heparin Sodium
- Manufacturer
- Hospira, Inc.
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 11 Sep 2014
- FDA classified
- 23 Dec 2014
- Reported
- 31 Dec 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Blood Thinners
Timeline
| 11 Sep 2014 | Recall initiated by company | |
| 23 Dec 2014 | Classified by FDA | +103 days |
| 31 Dec 2014 | 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
Presence of Particulate Matter: A particulate, confirmed as human hair, was found sealed between the tube and film at the round seal of the unused administrative port of the container.
Product as listed by the FDA
HEPARIN SODIUM, 1000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.9% Sodium Chloride Injection, 500 mL flexible container unit, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-7620-03
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: A particulate, confirmed as human hair, was found sealed between the tube and film at the round seal of the unused administrative port of the container.
Which lots are affected?
Lot #: 41-046-JT, Exp 11/01/2015
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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 Hospira
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|---|---|---|---|---|---|
| Drug | CLASS I | Infant 25% Dextrose Injection recalled by HospiraDextrose | Hospira | Particulate Matter | Nationwide |
| Device | CLASS II | Minibore Extension Set with Spin Lock Collar, Non-DEHP, Latex-Free recalled | Hospira | Other | Nationwide |
| Drug | CLASS III | 5% Lidocaine HCL and 7.5% Dextrose Injection, USP Single-dose ampule recalled | Hospira | Potency & Assay | PR |
| Drug | CLASS II | Fentanyl Citrate Injection, USP, 100 mcg Fentanyl recalled by Hospira | Hospira | Sterility | Nationwide |
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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 |