Bausch+Lomb is voluntarily recalling a number of batches of its ReNu Multi-Purpose Solution and ReNu MultiPlus MPS in Europe.
The company stated that routine testing showed that while these products were safe and effective when used as directed, they were not meeting B+L quality expectations. 'We decided to initiate the quality-related recall after our stability monitoring programme showed that the performance trend of certain lots did not meet our expectations. There is no indication of a safety or efficacy issue and there have been no reported adverse events rather, this recall is being conducted as a precaution.'
It added that the stability monitoring programme was designed to identify potential problems months before they occurred and was part of its drive to provide best-in-class manufacturing and quality processes.
B+L has notified retailers and eye care professionals about the steps they should take if they have product from the affected batches in their inventories.
The company has also recalled a single lot (AA120) of 120ml ReNu MultiPlus MPS in Croatia, Dubai, Hungary, Serbia, Romania, Turkey and Saudi Arabia, as a precaution over a small number of sensitivity issues with this lot. B+L said that the number of reports represented less than 0.1 per cent of the packs in this lot. It initiated a recall of the product as a precaution and has directly contacted retailers and ECPs who have been shipped the product to initiate the recall and inform them of the steps to take to return the product.
? In May 2006 ReNu MoistureLoc was withdrawn worldwide as its formulation, when combined with certain use patterns, was found likely to contribute to an increased risk of Fusarium keratitis.