Status
Terminated
Drug Enforcement D-395-2014
Lack of assurance of sterility; equipment failure led to potential breach in asceptic process.
Classification
Class II
Report Date
January 8, 2014
Termination Date
November 10, 2014
Product Information
- Product description
- 0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 50 mL, Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045. NDC #0409-9046-01.
- Product quantity
- 65109 vials
- Reason for recall
- Lack of assurance of sterility; equipment failure led to potential breach in asceptic process.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- US Nationwide.
Location & Firm
- Recalling firm
- Hospira Inc.
- Address
-
375 N Field Dr
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-395-2014
- Event ID
- 67045
- Recall initiation date
- October 11, 2013
- Center classification date
- January 2, 2014
- Code info
- Lot #32-484-EV, 32-485-EV Exp: 2/2015.
- More code info
- —