FDA says Bausch failed to report infections
May 16, 2006
WASHINGTON (Reuters) – Bausch & Lomb Inc. failed to notify
U.S. regulators about 35 serious fungal infections reported in
Singapore in users of its ReNu with MoistureLoc contact lens
solution within the required 30 days, the Food and Drug
Administration said in a report released on Tuesday.
The finding was among 20 observations of potential
violations the FDA listed after inspecting Bausch & Lomb
facilities in Greenville, South Carolina. The company
permanently pulled ReNu with MoistureLoc from the market on
Monday.
Source: reuters
