Dear Doctor Letter (Rote-Hand-Brief) on Virazole® (ribavirin) 6 g dry substance, powder to be reconstituted for aerosol administration: Problems with sterility and particle contamination at the manufacturing site
2011.12.23
Active substance: ribavirin
MEDA Pharma recommends only treating patients with Virazole® if its use is considered to be absolutely essential. In such cases the vials should be inspected visually for particle contamination prior to administration. Furthermore, suspected cases of co-infections (mycotic or bacterial) should be reported along with the numbers of the suspected batch(es). The background for this recommendation is the discovery of significant shortcomings in the Good Manufacturing Practice (GMP) at Venue Laboratories, the manufacturing site of Virazole®.
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