Teva Pharmaceutical, the maker of propofol, has received an FDA warning for manufacturing violations at its Irvine California facility. The violations included a failure to test each lot of raw materials used to make propofol, an injectable drug that is one of the most widely used medicines for general anesthesia. Propofol drew attention last June when it was implicated in the Michael Jackson death.
The FDA inspection that resulted in the FDA warning letter also led to the recall of 57,000 vials of propofol for elevated toxins. The FDA found 40 patients who had been affected by the toxic propofol.
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