CLASS I Drug recall · Reported 4 Sep 2013 · FDA Enforcement Report
9% Sodium Chloride Injection, USP flexible container recalled by Hospira
Hospira is recalling 9% Sodium Chloride Injection, USP flexible container, distributed nationwide in the US. The recall was initiated on 31 Aug 2012 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-922-2013
- FDA event ID
- 63364
- Recalling firm
- Hospira, Lake Forest, IL
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 31 Aug 2012
- FDA classified
- 26 Aug 2013
- Reported
- 4 Sep 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 31 Aug 2012 | Recall initiated by company | |
| 26 Aug 2013 | Classified by FDA | +360 days |
| 4 Sep 2013 | 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
Presence of Particulate Matter; product may contain fibrous material
Product as listed by the FDA
0.9% Sodium Chloride Injection, USP, 100 mL flexible container, Rx only, Hospira, Inc. Lake Forest, IL 60045 --- NDC 0409-7984-23
Where it was distributed
Nationwide
Questions about this recall
Is 9% Sodium Chloride Injection, USP flexible container recalled?
Yes. Hospira recalled 9% Sodium Chloride Injection, USP flexible container on 31 Aug 2012. The recall is Class I and its status is Terminated. Recall number D-922-2013.
Why was it recalled?
Presence of Particulate Matter; product may contain fibrous material
Which lots are affected?
Lot Number 05-201-JT, Expiration Date 1MAY2013
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 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 |