CLASS II Drug recall · Reported 26 Jun 2013 · FDA Enforcement Report
9% Sodium Chloride Injection, USP single dose Flexible recalled
Hospira is recalling 9% Sodium Chloride Injection, USP single dose Flexible, distributed nationwide in the US. The recall was initiated on 6 Jun 2013 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-608-2013
- FDA event ID
- 65400
- Recalling firm
- Hospira, Lake Forest, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Jun 2013
- FDA classified
- 20 Jun 2013
- Reported
- 26 Jun 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- Injectable & IV Drugs
Timeline
| 6 Jun 2013 | Recall initiated by company | |
| 20 Jun 2013 | Classified by FDA | +14 days |
| 26 Jun 2013 | Published in enforcement report | +6 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: The product has the potential for solution to leak at or near the administrative port of the primary container.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
0.9% Sodium Chloride Injection, USP, 250 mL single dose Flexible Plastic Container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-02
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Is 9% Sodium Chloride Injection, USP single dose Flexible recalled?
Yes. Hospira recalled 9% Sodium Chloride Injection, USP single dose Flexible on 6 Jun 2013. The recall is Class II and its status is Terminated. Recall number D-608-2013.
Why was it recalled?
Lack of Assurance of Sterility: The product has the potential for solution to leak at or near the administrative port of the primary container.
Which lots are affected?
Lot #: 16-031-JT*, Exp 1APR2014; Note the * may be followed by 01 or 02
Where was it sold?
Nationwide and 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 |