Nalbuphine HCl Injection, 20 mg/mL, 10 mL Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1467-01
Reported: December 26, 2012 Initiated: November 21, 2012 #D-096-2013
Product Description
Nalbuphine HCl Injection, 20 mg/mL, 10 mL Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1467-01
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.
Details
- Recalling Firm
- Hospira, Inc.
- Units Affected
- 145,400 vials
- Distribution
- Nationwide and Puerto Rico.
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
Nalbuphine HCl Injection, 20 mg/mL, 10 mL Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1467-01. Recalled by Hospira, Inc.. Units affected: 145,400 vials.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Drug on December 26, 2012. Severity: Moderate. Recall number: D-096-2013.
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