D-096-2013 Class II Terminated
FDA drug recall D-096-2013 was initiated by Hospira, Inc. on Nov 21, 2012 and is designated Class II. 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. The recall status is terminated (terminated Jun 3, 2014). Affected quantity: 145,400 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 26, 2012
- Initiation Date
- Nov 21, 2012
- Termination Date
- Jun 3, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 145,400 vials
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.
Distribution Pattern
Nationwide and Puerto Rico.
Code Information
Lot #: 11-293-DK, Exp 05/01/13
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-096-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026