Bausch+Lomb has voluntarily recalled three lots (C9116, C9009 and C9048) of ReNu Multi-Purpose Solution in Europe, Guadeloupe, Martinique and Reunion.
Routine testing showed these lots may not meet all specification criteria at the end of shelf life (C9116 and C9009 - March 2011, C9048 - April 2011).
The company stated that no other B+L products, or lots of ReNu, were affected by the quality-related recall, which was initiated when its Stability Monitoring Program, designed to identify potential problems, showed that the performance trend of certain lots did not meet its expectations. B+L added that the recall was being conducted as a precaution, with no indication of a safety or efficacy issue, with no reported adverse events.
The company added that it had contacted retailers and professionals who have been shipped this product to initiate the recall. 'However, due to the time elapsed since production we do not anticipate that there is any stock remaining,' said B+L.