Status
Terminated
Drug Enforcement D-66295-001
Lack of Assurance of Sterility; potential for vial breakage
Classification
Class II
Report Date
October 16, 2013
Termination Date
October 28, 2014
Product Information
- Product description
- 0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 10 mL, Single-Dose Vial, NDC 0409-9045-01, Hospira, Inc., Lake Forest, IL 60045
- Product quantity
- 187,150 vials
- Reason for recall
- Lack of Assurance of Sterility; potential for vial breakage
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Guam and Abu Dhabi
Location & Firm
- Recalling firm
- Hospira Inc.
- Address
-
275 N Field Dr, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-66295-001
- Event ID
- 66295
- Recall initiation date
- September 5, 2013
- Center classification date
- October 7, 2013
- Code info
- Lot 17-400-EV* and 17-401-EV * Note: the lot number may be followed by 01
- More code info
- —