Class I · High risk Terminated
PROPOFOL Injectable Emulsion
Reason Presence of particulate matter
Propofol1% 10mg/mL injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
What was recalled
Propofol1% 10mg/mL injection, 20 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0119-73
- Recalling firm
- Pharmakon Pharmaceuticals, Inc.
- NDC code
- 45183-0119-73
- Origin
- IN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1264-2016
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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