CLASS I Drug recall · Reported 13 May 2015 · FDA Enforcement Report
9% Sodium Chloride Injection recalled by Hospira
Hospira is recalling 9% Sodium Chloride Injection, USP, distributed nationwide in the US. The recall was initiated on 5 Mar 2015 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-0976-2015
- FDA event ID
- 70818
- Recalling firm
- Hospira, Lake Forest, IL
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 5 Mar 2015
- FDA classified
- 4 May 2015
- Reported
- 13 May 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 5 Mar 2015 | Recall initiated by company | |
| 4 May 2015 | Classified by FDA | +60 days |
| 13 May 2015 | 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: Confirmed finding of human hair floating in IV solution.
Product as listed by the FDA
0.9% Sodium Chloride Injection, USP, 250 mL, Rx only, VisIV Container, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-25.
Where it was distributed
Nationwide.
Questions about this recall
Is 9% Sodium Chloride Injection, USP recalled?
Yes. Hospira recalled 9% Sodium Chloride Injection, USP on 5 Mar 2015. The recall is Class I and its status is Terminated. Recall number D-0976-2015.
Why was it recalled?
Presence of Particulate Matter: Confirmed finding of human hair floating in IV solution.
Which lots are affected?
Lot # 45-110-C6; Exp 03/1/16
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
All 225| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |