Class I · High risk Terminated
PROPOFOL Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL glass fliptop vial (NDC 0409-4699-54) further packaged in…
Reason Presence of particulate matter
Is Propofol recalled?
20 FDA recalls mention Propofol. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Propofol.
Class I · High risk Terminated
Propofol Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL per glass fliptop vial (NDC 0409-4699-54) further…
Reason Presence of particulate matter: particulate identified as a beetle.
Class II · Moderate risk Terminated
Diprivan (Propofol) Emulsion, 200 mg per 20 mL (10mg/mL), 20 mL vial, Rx only, MFG: App Pharmaceutical LLC, NDC 63323-269-29
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Diprivan (Propofol) Emulsion, 100 mg/mL, 10mL vial, Rx only, MFG: App Pharmaceutical LLC, NDC 63323-269-10
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Propofol Injectable Emulsion, USP 200 mg per 20 mL (10 mg per mL), twenty-five 20 mL vials, Rx only, MFG: Teva Pharma USA, NDC…
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Propofol Injectable Emulsion, USP, 200 mg/ 20 mL (10 mg/mL), packaged in a) 50 mL vial, in packs of 20 (NDC 00591-2136-51), b)…
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Propofol1% 10mg/mL injection, 20 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single patient infusion vial, Contains Benzyl Alcohol, For I.V…
Reason Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.
Class I · High risk Terminated
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vials, packaged in 5 Units per carton…
Reason Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Class I · High risk Terminated
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), For I.V. Administration, Rx Only, 20 mL vial, Contains Benzyl Alcohol…
Reason 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…
Class II · Moderate risk Terminated
Propofol Injectible Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, packaged in 5 Units x 20 mL per…
Reason Presence of Particulate Matter: Glass defect located on the interior neck of the vial identified glass surface abrasions and visible embedded…
Class II · Moderate risk Terminated
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL single patient infusion vial packaged in 5 Units x 20 mL per…
Reason Presence of Particulate Matter: Visible particles embedded in the glass identified during a retain sample inspection.
Class II · Moderate risk Terminated
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), packaged in 5 Units x 20 mL Single patient infusion vials per carton…
Reason Presence of Particulate Matter: Visible particulate embedded in the glass vial was observed and confirmed in a sample bottle during retain sample…
Class II · Moderate risk Terminated
Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 mL, Single patient infusion vial, RX only, Hospira, Inc., Lake…
Reason Presence of Particulate Matter; single visible particulate was identified during a retain sample inspection identified as stainless steel
Class II · Moderate risk Terminated
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, Rx only, Hospira, Inc., Lake…
Reason Presence of Particulate Matter: A single visible particulate was identified during a retain sample inspection.
Class II · Moderate risk Terminated
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…
Reason Presence of Particulate Matter: Visible particulate embedded in vials was observed and confirmed in a sample bottle during retain inspection.
Class II · Moderate risk Terminated
Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30…
Reason Presence of Particulate Matter: Visible particulate and particulate embedded in vials were observed during retain inspection.
Class II · Moderate risk Terminated
Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30…
Reason Presence of Particulate Matter: A single visible particulate was observed and confirmed in sample bottles of the recalled lots during retain…
Class II · Moderate risk Terminated
Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 ml Single patient infusion vial, Rx only, Hospira, Inc. Lake Forest…
Reason Presence of Particulate Matter: A single visible particulate was observed and confirmed in a sample bottle during retain inspection.
Class II · Moderate risk Terminated
Propofol Injectable Emulsion, 1%, (10mg/mL), packaged in a) 200 mg/20 mL, 5 Units x 20 mL Single patient infusion vials per…
Reason Presence of Particulate Matter: A single visible particulate was observed in a retention sample bottles identified as stainless steel
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