The batches shown in Table 1 of Targocid 200 mg powder for injection/infusion or oral solution are being recalled immediately by Sanofi UK. This is due to out of specification results for bacterial endotoxins, as confirmed by testing of retain samples. This problem was discovered after a medical adverse event in which four patients developed a high grade of fever within three hours of receiving vials from the impacted batches.
There is a potential life-threatening or serious risk to patient health as a result of the out-of-spec results observed.
Medical professionals should be aware of the following symptoms if they arise: A high temperature (fever) or low body temperature, chills and shivering, cold, clammy and pale or mottled skin, a fast heartbeat, fast breathing, severe breathlessness, severe muscle pain, feeling dizzy or faint, a change in mental state - such as confusion or disorientation, loss of consciousness, slurred speech, nausea and vomiting and/or diarrhoea, nausea and vomiting and/or diarrhoea.
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