Propofol Injectable Emulsion 10 mg/mL 100 mL vials Recalled

Teva Pharmaceuticals USA is initiating a recall of Propofol Injectable Emulsion 10 mg/mL 100 mL vials, lot numbers 31305429B and 31305430B. The product lots identified are being recalled due to the presence of elevated endotoxin levels in some vials within these lot numbers.

Teva has been notified of 41 propofol-treated patients who experienced post-operative fever, chills and other flu-like symptoms. Based on available information it appears that all febrile or flu-like reactions were self-limiting with spontaneous resolution.

Adverse health effects, such as fever, chills, or rigors, are possible with exposure to product with elevated levels of endotoxins. Serious adverse effects, such as disseminated intravascular coagulopathy, acute respiratory distress syndrome, shock, and death, are possible with exposure to product with high endotoxin levels.

JULY-17-09: Propofol Injectable Emulsion 10 mg/mL 100 mL vials Recalled [FDA: PROPOFOL INJECTABLE EMULSION RECALLED]

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Published on Jul-17-09