Status
Terminated
Drug Enforcement D-099-2013
Presence of Particulate Matter: Report of a vial containing visible particulate matter embedded in the glass wall which has the potential to dislodge resulting in the presence of particulate matter in the product.
Classification
Class II
Report Date
December 26, 2012
Termination Date
May 8, 2014
Product Information
- Product description
- Lidocaine HCl Injection, USP, 1% (10 mg/mL), 30 mL Single-dose Teartop Vial, packaged in 25-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045; NDC 0409-4279-02.
- Product quantity
- 120,350 vials
- Reason for recall
- Presence of Particulate Matter: Report of a vial containing visible particulate matter embedded in the glass wall which has the potential to dislodge resulting in the presence of particulate matter in the product.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
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-099-2013
- Event ID
- 63913
- Recall initiation date
- October 4, 2012
- Center classification date
- December 20, 2012
- Code info
- Lot #: 14-277-DK*, Exp 02/01/14; * may be followed by 01
- More code info
- —