Recalls / Class I
Class ID-1547-2014
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), For I.V. Administration, Rx Only, 20 mL vial, Contains Benzyl Alcohol, Hospira, Inc., Lake Forest, IL 60045 USA, 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 #s: 29-614-DJ, 29-615-DJ, 29-616-DJ, 29-617-DJ, 29-628-DJ, 29-629-DJ, 29-630-DJ, Exp 05/01/2015
Why it was recalled
Presence of Particulate Matter: A glass defect was found on the interior neck of the vial during a retain sample inspection where the glass vial contained visible embedded metallic particulate and free floating metallic particulates were also found in solution.
Recalling firm
- Firm
- Hospira Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 844,300 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-04-02
- FDA classified
- 2014-08-20
- Posted by FDA
- 2014-08-27
- Terminated
- 2015-05-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1547-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.