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
Nationwide Recall of NuCel Labs Eye Drops and Eye/Ear Wash Products
Contact:
Kevin Lundquist
208-542-0325
FOR IMMEDIATE RELEASE -- January 29, 2008 -- NuCel Labs of Idaho Falls, Idaho announced today that it is conducting a voluntary nationwide recall of all Eye Drops and Eye/Ear Wash. This recall follows an FDA inspection in which product testing indicated that there was bacteria and particulate matter in the product 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.
Products are packaged in 1/4 oz plastic bottles. Eye drops are labeled: Eye Drops Caution: Do Not Use With Implants. Wash is labeled Eye/Ear Wash. All products labeled "Eye Drops Caution: Do Not Use With Implants" or "Eye/Ear Wash" are subject to the recall action. There are no lot numbers or expiration dates on the product. Approximately 500 units of these products have been distributed nationwide through retail outlets and the internet.
No illnesses or injuries have been reported to date.
The company has ceased the production and distribution of the product. Consumers who may have any of these products on hand are advised not to use them. Consumers are asked to return them to NuCel Lab, 1380 Curtis Ave, Idaho Falls, Idaho 83402 or discard them and send NuCel Lab a purchase receipt for a full refund. Consumers with questions may call NuCel Lab at 208-542-0325.
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