This is a definitive report.This was reported from a staff of physician's clinic and the physician confirmed the event.According to the physician's staff, they were wondering if the injection was possibly contaminated, because they were unsure of why he got so ill.Injection physician stated it was very unlikely that the injection was contaminated or that it caused his infections.According to the result of investigation, there were no deviations or out-of-specifications found in the manufacturing process, the in-process testing, the release testing, and the environmental monitoring for lot no.4x7c29.Furthermore, no infectious event has been reported from other facilities in the us except for this case, the urinary tract infection was therefore not related to product quality.It was considered that the causal relationship was "not related" because community-acquired infection could be suspected.(b)(4).
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