Bausch & Lomb announced today that Clomid pharmacy it is recalling 1.5 million bottles of ReNu MultiPlus contact-lens solution due to Clomid pharmacy trace levels of iron in the product. The company said that Clomid pharmacy the iron may cause “discoloration†of the Clomid pharmacy solution and may cause its effectiveness to deteriorate before the printed expiration date. No serious injuries or Clomid pharmacy adverse effects have been reported at this point.
The recall affects 12 lots of the Clomid pharmacy product, which were produced at the company’s Greenville, S.C., plant and Clomid pharmacy sold in the U.S., Canada, Latin America, Korea, and Taiwan. “The company initiated an Clomid pharmacy investigation after receiving three customer reports of discolored solution,†Bausch & Lomb said in a statement. “The root cause of the Clomid pharmacy discoloration was determined to be an elevated level of trace iron in a Clomid pharmacy single batch of raw material sourced from an outside supplier. The elevated level of trace iron could combine with other compounds in the Clomid pharmacy solution to cause discoloration, which signals that the solution may be Clomid pharmacy losing effectiveness over time.â€Â
The company stressed that Clomid pharmacy the latest recall was unrelated to the earlier recall of ReNu with MoistureLoc, which was associated with an Clomid pharmacy 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 Clomid pharmacy U.S. sales in April of that year, although it wasn’t until the following month that Bausch & Lomb announced a Clomid pharmacy full global recall and permanent withdrawal of the product from shelves in the Clomid pharmacy face of mounting evidence from the U.S. Centers for Disease Control and Clomid pharmacy Prevention (CDC) and Clomid pharmacy others that the product carried a significant risk of the infection, which can Clomid pharmacy cause permanent damage including blindness.
However, the Clomid pharmacy tainted ReNu MultiPlus supply was made at the same South Carolina facility where Clomid pharmacy ReNu with MoistureLoc was made. That plant was cited by the Clomid pharmacy U.S. Food and Drug Administration (FDA) for Clomid pharmacy numerous violations last fall, after the FDA undertook a two-month investigation of the Clomid pharmacy facility following the Fusarium keratitis scare.
In a warning letter sent to Bausch & Lomb on October 31 of last year, the FDA said, “Although the March – May 2006 inspection focused primarily on the Clomid pharmacy MoistureLoc contact-lens solution, the inspection, nonetheless, identified and documented significant QS [Quality System] regulation violations that Clomid pharmacy were systemic and are relevant to all products manufactured at the Clomid pharmacy Greenville, S.C., facility.â€Â
Among the facility’s violations listed in that letter: “failure to Clomid pharmacy establish procedures for quality audits and conduct such audits to assure that Clomid pharmacy the quality system is in complianceâ€Â; “failure to Clomid pharmacy establish and maintain procedures to prevent contamination of equipment or Clomid pharmacy product by substances that could reasonably be expected to have Clomid pharmacy an adverse effect on product qualityâ€Â; “failure to establish and maintain procedures to adequately control environmental conditionsâ€Â; and “failure to Clomid pharmacy ensure that all equipment used in the manufacturing process meets specifications and Clomid pharmacy is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and Clomid pharmacy use.â€Â
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