• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Bausch & Lomb Initiates Limited Voluntary Recall of Twelve Lots of ReNu MultiPlus Solutions Due to Potential for Shortened Shelf Life

Contact:
Bausch & Lomb
1-866-259-8255

FOR IMMEDIATE RELEASE -- Rochester, New York -- March 6, 2007 -- Bausch & Lomb (NYSE/BOL) has initiated a limited voluntary recall from distribution centers and retail shelves in the United States and specific other countries of 12 lots of ReNu MultiPlus lens care solution made at its plant in Greenville, SC because they contain an elevated level of trace iron. This may result in discoloration of the solution in some bottles, and the shelf life of the product may be shortened to less than its two-year expiration date, due to a potential loss of effectiveness over time. The Company has received no reports of serious adverse events associated with these lots and believes virtually all of the affected product, manufactured about a year ago, has already been used by consumers. Bausch & Lomb has notified the U.S. Food and Drug Administration of this voluntary action.

About a million bottles of solution from nine of the 12 lots were originally distributed in the United States. Product from the 12 affected lots was also distributed in Canada, Latin America, Korea and Taiwan, where it is also being recalled.

The company initiated an investigation after receiving three customer reports of discolored solution. 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. Iron is an element present at trace levels – measured in parts per billion – in many compounds used in manufacturing food, drug, medical device and cosmetic products for human use. 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.

"We have always maintained that the health and safety of consumers is our top priority," said Angela J. Panzarella, vice president and head of Bausch & Lomb's global vision care business. "With detailed and specific information about the distribution of the affected product, and good information about consumer use patterns, we are highly confident that virtually all of the affected product was used before it began to lose effectiveness. We're now in the process of confirming with distributors and retailers that there is no product still available for sale anywhere."

"We are confident we have identified the source of the problem and we are taking appropriate measures designed to avoid a recurrence," Panzarella said.

Bausch & Lomb does not expect the costs associated with this limited recall will have a significant impact on its financial results.

If consumers notice that their lens care solution appears to be discolored, they should discard it, as it may be losing effectiveness. The recalled lots all carry the expiration date "2008 – 03" on the bottle. Consumers who have bottles from the lot numbers listed below should check the Company's web site at www.bausch.com/productrecall or call the consumer affairs line (1-866-259-8255) to arrange for a replacement.

LOT NUMBERS SUBJECT TO RECALL: GC6030 – GC6037 – GC6038 – GC6045 – GC6048 – GC6052 – GC6061 – GC6063 – GC6072 – GC6073 – GC6080 – GC6085

####

RSS Feed for FDA Recalls Information [ what's this?]