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Class II: temporary or reversible health riskTerminated

Hospira Nalbuphine HCl Injection Recall

Nalbuphine HCl Injection, 20 mg/mL, 10 mL Multiple-dose Fliptop Vial, Rx only, Hospira,…

Hospira, Inc. · Lake Forest, IL

Risk level
Class II
Reported by FDA
Dec 26, 2012
Recall ID
D-096-2013
Check your lot numberHow we source this data

Summary

Hospira recalled Nalbuphine HCl Injection starting Nov 21, 2012. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-096-2013 on Dec 26, 2012. Reason: 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. Status: Terminated.

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.

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

Lot numbers, UPCs & expiration codes

Lot #: 11-293-DK, Exp 05/01/13

Where it was sold

Nationwide and Puerto Rico.

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-096-2013
Classification
Class II
Status
Terminated
Recall initiated
Nov 21, 2012
FDA report date
Dec 26, 2012
Quantity
145,400 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Hospira, Inc.

Original FDA data

Every field from FDA enforcement report D-096-2013, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
63884
Address
600 N Field Dr Bldg J45
Code information
Lot #: 11-293-DK, Exp 05/01/13
Postal code
60045
Report date
Dec 26, 2012
Product type
Drugs
Recall number
D-096-2013
Classification
Class II
Recalling firm
Hospira, Inc.
Product quantity
145,400 vials
Termination date
Jun 3, 2014
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.
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide and Puerto Rico.
Recall initiation date
Nov 21, 2012
Initial firm notification
Letter
Center classification date
Dec 20, 2012

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-096-2013, published Dec 26, 2012. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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