Status
Terminated
Drug Enforcement D-1382-2012
Presence of Particulate Matter: A single visible particulate was observed in a retention sample bottles identified as stainless steel
Classification
Class II
Report Date
June 20, 2012
Termination Date
June 27, 2013
Product Information
- Product description
- Propofol Injectable Emulsion, 1%, (10mg/mL), packaged in a) 200 mg/20 mL, 5 Units x 20 mL Single patient infusion vials per carton (NDC 0409-4699-30); b) 1 g/100 mL, 10 Units x 100 mL Single patient infusion vials per carton (NDC 0409-4699-24); Rx only, Hospira, Inc., Lake Forest, IL 60045, USA.
- Product quantity
- a) 36,125 vials; b) 31,280 vials
- Reason for recall
- Presence of Particulate Matter: A single visible particulate was observed in a retention sample bottles identified as stainless steel
- 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-1382-2012
- Event ID
- 62009
- Recall initiation date
- April 11, 2012
- Center classification date
- June 14, 2012
- Code info
- Lot #: a) 03440DJ*, Exp 1MAR2013; b) 07947DJ, Exp 1JUL2013; 10134DJ, Exp 1OCT2013; Note: * the lot may be followed by 01.
- More code info
- —