Bausch & Lomb announced today that it is recalling 1.5 million bottles of ReNu MultiPlus contact-lens solution due to trace levels of iron in the product. The company said that the iron may cause Ã¢â‚¬Å“discolorationÃ¢â‚¬Â of the solution and may cause its effectiveness to deteriorate before the printed expiration date. No serious injuries or adverse effects have been reported at this point.
The recall affects 12 lots of the product, which were produced at the companyÃ¢â‚¬â„¢s Greenville, S.C., plant and sold in the U.S., Canada, Latin America, Korea, and Taiwan. Ã¢â‚¬Å“The company initiated an investigation after receiving three customer reports of discolored solution,Ã¢â‚¬Â Bausch & Lomb said in a statement. Ã¢â‚¬Å“The root cause of the discoloration was determined to be an elevated level of trace iron in a single batch of raw material sourced from an outside supplier. The elevated level of trace iron could combine with other compounds in the solution to cause discoloration, which signals that the solution may be losing effectiveness over time.Ã¢â‚¬Â
The company stressed that the latest recall was unrelated to the earlier recall of ReNu with MoistureLoc, which was associated with an outbreak of the severe fungal eye infection known as Fusarium keratitis. The company suspended Asian sales of ReNu with MoistureLoc in February of 2006 and U.S. sales in April of that year, although it wasnÃ¢â‚¬â„¢t until the following month that Bausch & Lomb announced a full global recall and permanent withdrawal of the product from shelves in the face of mounting evidence from the U.S. Centers for Disease Control and Prevention (CDC) and others that the product carried a significant risk of the infection, which can cause permanent damage including blindness.
However, the tainted ReNu MultiPlus supply was made at the same South Carolina facility where ReNu with MoistureLoc was made. That plant was cited by the U.S. Food and Drug Administration (FDA) for numerous violations last fall, after the FDA undertook a two-month investigation of the facility following the Fusarium keratitis scare.
In a warning letter sent to Bausch & Lomb on October 31 of last year, the FDA said, Ã¢â‚¬Å“Although the March – May 2006 inspection focused primarily on the MoistureLoc contact-lens solution, the inspection, nonetheless, identified and documented significant QS [Quality System] regulation violations that were systemic and are relevant to all products manufactured at the Greenville, S.C., facility.Ã¢â‚¬Â
Among the facilityÃ¢â‚¬â„¢s violations listed in that letter: Ã¢â‚¬Å“failure to establish procedures for quality audits and conduct such audits to assure that the quality system is in complianceÃ¢â‚¬Â; Ã¢â‚¬Å“failure to establish and maintain procedures to prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect on product qualityÃ¢â‚¬Â; Ã¢â‚¬Å“failure to establish and maintain procedures to adequately control environmental conditionsÃ¢â‚¬Â; and Ã¢â‚¬Å“failure to ensure that all equipment used in the manufacturing process meets specifications and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use.Ã¢â‚¬Â