Status
Terminated
Drug Enforcement D-096-2013
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.
Classification
Class II
Report Date
December 26, 2012
Termination Date
June 3, 2014
Product Information
- 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
- Product quantity
- 145,400 vials
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico.
Location & Firm
- Recalling firm
- Hospira, Inc.
- Address
-
600 N Field Dr Bldg J45
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-096-2013
- Event ID
- 63884
- Recall initiation date
- November 21, 2012
- Center classification date
- December 20, 2012
- Code info
- Lot #: 11-293-DK, Exp 05/01/13
- More code info
- —