Recalls / Class II
Class IID-1382-2012
Product
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.
- Brand name
- Propofol
- Generic name
- Propofol
- Active ingredient
- Propofol
- Route
- Intravenous
- NDCs
- 0409-4699, 0409-6010
- FDA application
- ANDA077908
- Affected lot / code info
- Lot #: a) 03440DJ*, Exp 1MAR2013; b) 07947DJ, Exp 1JUL2013; 10134DJ, Exp 1OCT2013; Note: * the lot may be followed by 01.
Why it was recalled
Presence of Particulate Matter: A single visible particulate was observed in a retention sample bottles identified as stainless steel
Recalling firm
- Firm
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 600 N Field Dr Bldg J45, Lake Forest, Illinois 60045
Distribution
- Quantity
- a) 36,125 vials; b) 31,280 vials
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2012-04-11
- FDA classified
- 2012-06-14
- Posted by FDA
- 2012-06-20
- Terminated
- 2013-06-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1382-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.