CLASS II Drug recall · Reported 5 Feb 2014 · FDA Enforcement Report
Heparin Sodium 2000 USP Heparin Units recalled by Hospira
Hospira is recalling Heparin Sodium 2000 USP Heparin Units per (2 USP Heparin Units/mL) in 9% Sodium Chloride, distributed nationwide in the US. The recall was initiated on 9 Jan 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-1036-2014
- FDA event ID
- 67317
- Recalling firm
- Hospira, Lake Forest, IL
- Brand
- Heparin Sodium
- Manufacturer
- Hospira, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Jan 2014
- FDA classified
- 24 Jan 2014
- Reported
- 5 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Blood Thinners
Timeline
| 9 Jan 2014 | Recall initiated by company | |
| 24 Jan 2014 | Classified by FDA | +15 days |
| 5 Feb 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility; potential leakage from administrative port.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Heparin Sodium 2000 USP Heparin Units per 1000 mL (2 USP Heparin Units/mL) in 0.9% Sodium Chloride Injection, Rx only. Hospira, Lake Forest, IL 60045. NDC 0409-7620-59.
Where it was distributed
Nationwide including Puerto Rico
Questions about this recall
Is Heparin Sodium 2000 USP Heparin Units per (2 USP Heparin Units/mL) in 9% Sodium Chloride recalled?
Yes. Hospira recalled Heparin Sodium 2000 USP Heparin Units per (2 USP Heparin Units/mL) in 9% Sodium Chloride on 9 Jan 2014. The recall is Class II and its status is Terminated. Recall number D-1036-2014.
Why was it recalled?
Lack of Assurance of Sterility; potential leakage from administrative port.
Which lots are affected?
Lot #: 26-125-JT, Exp: 8/14
Where was it sold?
Nationwide including Puerto Rico
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 21 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 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 |
| Device | CLASS II | LifeCare PCA 3, PCA recalled by Hospira | Hospira | Device Malfunction | Nationwide |
Other Heparin recalls
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Heparin (Heparin Sodium in 9% Sodium Chloride Injection) recalledHeparin Sodium In Sodium Chloride | Baxter Healthcare | Sterility | 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 2,000, USP Units, per (2 USP Units/mL) recalled by PfizerHeparin Sodium | Pfizer | Sterility | Nationwide |
| Drug | CLASS II | Heparin injection, Preservative Free, a), b) syringe, c) recalled | Walgreens Infusion Services | Sterility | TX |
| Drug | CLASS I | Heparin Sodium Injection USP 25,000 USP Units added to recalled | Pharmedium Services | Particulate Matter | Nationwide |