CLASS II Drug recall · Reported 3 Jul 2013 · FDA Enforcement Report
9% Sodium Chloride Irrigation recalled by Hospira
Hospira is recalling 9% Sodium Chloride Irrigation, USP, distributed nationwide in the US. The recall was initiated on 4 May 2012 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-617-2013
- FDA event ID
- 61918
- Recalling firm
- Hospira, Lake Forest, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 May 2012
- FDA classified
- 21 Jun 2013
- Reported
- 3 Jul 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 4 May 2012 | Recall initiated by company | |
| 21 Jun 2013 | Classified by FDA | +413 days |
| 3 Jul 2013 | 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: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
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
0.9% Sodium Chloride Irrigation, USP, 3000 mL, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08
Where it was distributed
Nationwide Puerto Rico, U.S. Virgin Island, Libya, Saudi Arabia
Questions about this recall
Is 9% Sodium Chloride Irrigation, USP recalled?
Yes. Hospira recalled 9% Sodium Chloride Irrigation, USP on 4 May 2012. The recall is Class II and its status is Terminated. Recall number D-617-2013.
Why was it recalled?
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
Which lots are affected?
Lots #: 04-151-JT, 06-040-JT, Exp 4/13
Where was it sold?
Nationwide Puerto Rico, U.S. Virgin Island, Libya, Saudi Arabia
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 |