PROPOFOL

Generic: PROPOFOL

Sagent PharmaceuticalsManufacturer

INTRAVENOUSRoute

PROPOFOLActive Substance

1999-01-04Original Approval

PROPOFOL is FDA application ANDA075102, sponsored by SAGENT PHARMS INC. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2013-05-25

Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 mL, Single patient infusion vial, RX only, Hospira, Inc., L

Presence of Particulate Matter; single visible particulate was identified during a retain sample ins

Class II2013-04-08

Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, Rx only, Hospira, Inc., L

Presence of Particulate Matter: A single visible particulate was identified during a retain sample i

Class II2013-12-12

Propofol Injectible Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, packaged in 5 Units x 20

Presence of Particulate Matter: Glass defect located on the interior neck of the vial identified gla

Class II2013-08-14

Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), packaged in 5 Units x 20 mL Single patient infusion vials per

Presence of Particulate Matter: Visible particulate embedded in the glass vial was observed and conf

Class I2014-10-06

Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vials, packaged in 5 Units per

Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.

Class I2022-08-22

PROPOFOL Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL glass fliptop vial (NDC 0409-4699-54) further pa

Presence of particulate matter

Class II2013-02-25

Propofol Injectable Emulsion, 1%, packaged in a) 5 x 20 mL Single patient infusion vials per carton, 200 mg/20 mL (10 mg

Presence of Particulate Matter: Visible particulate embedded in vials was observed and confirmed in

Class II2014-12-23

Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single patient infusion vial, Contains Benzyl Alcohol,

Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck

Class II2012-04-11

Propofol Injectable Emulsion, 1%, (10mg/mL), packaged in a) 200 mg/20 mL, 5 Units x 20 mL Single patient infusion vials

Presence of Particulate Matter: A single visible particulate was observed in a retention sample bott

Class I2022-07-13

Propofol Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL per glass fliptop vial (NDC 0409-4699-54) furthe

PROPOFOL

Recalls

Top Reported Reactions