FDA MedWatch- NuCel Labs Eye Drops and Eye/Ear Wash- Nationwide Recall Because Of The Presence Of Bacteria And Particulate Matter

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Date: Thu, 31 Jan 2008 13:05:42 -0600 (CST)From: "U.S. Food & Drug Administration (FDA)" <fda@...>Subject: FDA MedWatch- NuCel Labs Eye Drops and Eye/Ear Wash- NationwideRecall Because Of The Presence Of Bacteria And Particulate Mattercarwol@...MedWatch logo MedWatch - The FDA Safety Information and Adverse Event Reporting Program NuCel Labs and FDA informed consumers and healthcare professionals of a voluntary nationwide recall of all Eye Drops and Eye/War Wash Products. The products were recalled after testing indicated the presence of bacteria and particulate matter, deeming these

products non-sterile. Non-sterile eye drops pose an unacceptable risk of causing eye infections, which in rare cases could lead to blindness. No illnesses or injuries have been reported to date. There are no lot numbers or expiration dates on the products. Consumers who have the product should discontinue use of the product and return it to NuCel Lab. See the manufacturer's press release for return shipping information. Read the complete 2008 MedWatch Safety Summary, including a link to the Manufacturer's Press Release regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#NuCel