CLASS II Drug recall · Reported 26 Dec 2012 · FDA Enforcement Report
Nalbuphine HCl Injection, 20 mg/mL Multiple-dose Fliptop Vial recalled
Hospira is recalling Nalbuphine HCl Injection, 20 mg/mL Multiple-dose Fliptop Vial, distributed nationwide in the US. The recall was initiated on 21 Nov 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-096-2013
- FDA event ID
- 63884
- Recalling firm
- Hospira, Lake Forest, IL
- Manufacturer
- Hospira, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Nov 2012
- FDA classified
- 20 Dec 2012
- Reported
- 26 Dec 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 21 Nov 2012 | Recall initiated by company | |
| 20 Dec 2012 | Classified by FDA | +29 days |
| 26 Dec 2012 | 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: Complains of a loose crimp applied to the fliptop vial; and a missing stopper and flip cap were received and therefore sterility cannot be assured.
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
Nalbuphine HCl Injection, 20 mg/mL, 10 mL Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1467-01
Where it was distributed
Nationwide and Puerto Rico.
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Complains of a loose crimp applied to the fliptop vial; and a missing stopper and flip cap were received and therefore sterility cannot be assured.
Which lots are affected?
Lot #: 11-293-DK, Exp 05/01/13
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 26 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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| Drug | CLASS I | Infant 25% Dextrose Injection recalled by HospiraDextrose | Hospira | Particulate Matter | Nationwide |
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| Drug | CLASS III | 5% Lidocaine HCL and 7.5% 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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Other Nalbuphine recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Nalbuphine 10 mg/mL injection solution recalled | Martin Avenue Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Nalbuphine HCL 20 MG/ML Injectable, all presentations recalled | Beacon Hill Medical Pharmacy, P.C | Sterility | Nationwide |