The United States Food and Drug Administration (FDA) has issued a warning to consumers not to purchase or use the EzriCare artificial tears product due to potential contamination.
In a statement issued Wednesday, the FDA warned that testing conducted by the manufacturer, Allergan Pharmaceuticals LLC, uncovered trace levels of Burkholderia cepacia, a type of bacteria that can cause serious, sometimes fatal, infections. These infections may be life-threatening in people with weakened immune systems or pre-existing conditions such as COPD, cystic fibrosis, or diabetes.
The FDA has not received reports of any adverse events related to the use of this product, but it is encouraging users to stop using the product immediately and discard any remaining product. The product, distributed between May and July of 2020, was sold in a 5mL bottle size and can be identified by the National Drug Code (NDC) 61748-083-15.
The FDA also recommends those who have used the product to consult a doctor if they have any signs or symptoms of an infection related to contaminates, such as fever or general feeling of being unwell. If a person believes they have an infection, they are encouraged to seek medical advice.
Both the FDA and Allergan Pharmaceuticals are currently investigating the source of the contamination. The FDA is working diligently to ensure the safety of consumers and warn them about any potential risks associated with the use of medications and other products.