CLASS II Drug recall · Reported 3 Dec 2014 · FDA Enforcement Report
45% Sodium Chloride Injection, USP container recalled by Hospira
Hospira is recalling 45% Sodium Chloride Injection, USP container, distributed nationwide in the US. The recall was initiated on 14 Oct 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-0286-2015
- FDA event ID
- 69494
- Recalling firm
- Hospira, Lake Forest, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Oct 2014
- FDA classified
- 25 Nov 2014
- Reported
- 3 Dec 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 14 Oct 2014 | Recall initiated by company | |
| 25 Nov 2014 | Classified by FDA | +42 days |
| 3 Dec 2014 | Published in enforcement report | +8 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 of punctures through the overwrap and primary container which may result in IV bag leaks.
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
0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7985-09.
Where it was distributed
Nationwide, Puerto Rico, and U.S. Virgin Islands.
Questions about this recall
Is 45% Sodium Chloride Injection, USP container recalled?
Yes. Hospira recalled 45% Sodium Chloride Injection, USP container on 14 Oct 2014. The recall is Class II and its status is Terminated. Recall number D-0286-2015.
Why was it recalled?
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Which lots are affected?
Lot # 33-027-JT; Exp.09/15 Lot # 33-045-JT; Exp.09/15 Lot # 33-097-JT; Exp.09/15 Lot # 35-068-JT; Exp.11/15 Lot # 36-112-JT; Exp.12/15 Lot # 37-012-JT; Exp.01/15
Where was it sold?
Nationwide, Puerto Rico, and U.S. Virgin Islands.
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.
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|---|---|---|---|---|---|
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| 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 |
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