Recalls / Class II
Class IID-1672-2012
Product
Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 ml Single patient infusion vial, Rx only, Hospira, Inc. Lake Forest, IL 60045 USA, NDC 0409-4699-24
- Brand name
- Propofol
- Generic name
- Propofol
- Active ingredient
- Propofol
- Route
- Intravenous
- NDCs
- 0409-4699, 0409-6010
- FDA application
- ANDA077908
- Affected lot / code info
- 07-893-DJ, exp. 7/2013, 10-123-DJ, 10-125-DJ, exp. 10/2013
Why it was recalled
Presence of Particulate Matter: A single visible particulate was observed and confirmed in a sample bottle during retain inspection.
Recalling firm
- Firm
- Hospira Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 375 N Field Dr, N/A, Lake Forest, Illinois 60045-2513
Distribution
- Quantity
- 56,420 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-08-03
- FDA classified
- 2012-08-30
- Posted by FDA
- 2012-09-05
- Terminated
- 2014-05-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1672-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.