Reported Dec 26, 2012 · Terminated
Nalbuphine HCl Injection, 20 mg/mL, 10 mL Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045,…
Hospira, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hospira, Inc. · 600 N Field Dr Bldg J45 · Lake Forest, IL · 60045
Is this the product you have?
- Nalbuphine HCl Injection, 20 mg/mL, 10 mL Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1467-01
- Lot codes and dates
Lot #: 11-293-DKExp 05/01/13
- Amount recalled
- 145,400 vials
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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