Recalls / Class II
Class IID-096-2013
Product
Nalbuphine HCl Injection, 20 mg/mL, 10 mL Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1467-01
- Brand name
- Nalbuphine Hydrochloride
- Generic name
- Nalbuphine Hydrochloride
- Active ingredient
- Nalbuphine Hydrochloride
- Route
- Intramuscular, Intravenous, Subcutaneous
- NDCs
- 0409-1463, 0409-1465, 0409-1464, 0409-1467
- FDA application
- ANDA070914
- Affected lot / code info
- Lot #: 11-293-DK, Exp 05/01/13
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.
Recalling firm
- Firm
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 600 N Field Dr Bldg J45, Lake Forest, Illinois 60045
Distribution
- Quantity
- 145,400 vials
- Distribution pattern
- Nationwide and Puerto Rico.
Timeline
- Recall initiated
- 2012-11-21
- FDA classified
- 2012-12-20
- Posted by FDA
- 2012-12-26
- Terminated
- 2014-06-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-096-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.