NuCel Eye Drops, Ear Wash Recalled Due to ContaminationJan 31, 2008 | Parker Waichman LLP
NuCel-brand eye drops and eye-ear wash are subject to a voluntary, nationwide recall due to possible contamination, the U.S. Food and Drug Administration (FDA) announced today. According to the FDA, the NuCel products are not sterile.
NuCel Labs of Idaho Falls, Idaho, initiated the nationwide recall following an FDA inspection in which testing indicated there was bacteria and particulate matter in the defective drugs, presenting a health risk. Non-sterile eye drops pose a risk of causing eye infections, which in rare cases could lead to blindness.
The recalled products are packaged in 1/4 ounce bottles bearing no lot numbers or expiration dates, the FDA said, noting approximately 500 units of the products have been distributed nationwide through retail outlets and the Internet.
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.
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.