Class I · High risk Terminated
PROPOFOL Injectable Emulsion
Reason Presence of particulate matter
Propofol Injectable Emulsion
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of Particulate Matter: Visible particulate embedded in vials was observed and confirmed in a sample bottle during retain inspection.
What was recalled
Propofol Injectable Emulsion, 1%, packaged in a) 5 x 20 mL Single patient infusion vials per carton, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 10 x 100 mL Single patient infusion vials per carton, 1 g/100 mL (10 mg/mL), NDC 0409-4699-24; Rx only, Hospira, Inc., Lake Forest, IL 60045 USA.
- Recalling firm
- Hospira Inc.
- NDC code
- 0409-4699-30
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-223-2013
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Propofol recalls
See all
Class I · High risk Terminated
Propofol Injectable Emulsion
Reason Presence of particulate matter: particulate identified as a beetle.
Class II · Moderate risk Terminated
Diprivan
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Diprivan
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Propofol Injectable Emulsion
Reason cGMP deviations: Temperature abuse
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