Recalls / Class II
Class IID-932-2013
Product
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), packaged in 5 Units x 20 mL Single patient infusion vials per carton, Rx only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-4699-30
- Brand name
- Propofol
- Generic name
- Propofol
- Active ingredient
- Propofol
- Route
- Intravenous
- NDCs
- 0409-4699, 0409-6010
- FDA application
- ANDA077908
- Affected lot / code info
- Lot #: 24-461-DJ*, Exp 12/14; 26-543-DJ*, Exp 02/15; 27-555-DJ*, 27-559-DJ*, Exp 03/15; *lot number may be followed by 01
Why it was recalled
Presence of Particulate Matter: Visible particulate embedded in the glass vial was observed and confirmed in a sample bottle during retain sample inspection.
Recalling firm
- Firm
- Hospira Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, N/A, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 283,150 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-08-14
- FDA classified
- 2013-09-09
- Posted by FDA
- 2013-09-18
- Terminated
- 2014-09-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-932-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.