Bausch & Lomb announced Tuesday that it is recalling 12 lots of ReNu MultiPlus lens care solution produced at its plant in Greenville, S.C., due to an elevated level of trace iron.
The iron may cause the solution to discolor and shorten the shelf life of the product. The company said it has not received any reports of serious problems from consumers.
Bausch & Lomb has notified the FDA of the recall.
The company said a million bottles from nine of the 12 affected lots were distributed in the U.S. The remaining bottles were distributed in Canada, Latin America, Korea and Taiwan and are also being recalled.
An investigation was launched after three customers reported discolored solution. The cause of the discoloration was an elevated level of trace iron in a single batch of raw material from an outside supplier.
“We are confident we have identified the source of the problem and we are taking appropriate measures designed to avoid a recurrence,” said Angela J. Panzarella, vice president and head of Bausch & Lomb’s global vision care business.