Recalls

Eye drops, nasal drops recalled due to sterility issues

Several brands of over-the-counter eye drops and nasal drops are being recalled by the Food and Drug Administration (FDA) because the manufacturing facility where the products were made cannot assure the sterility of the products. If not sterile, these products have the potential to cause eye infections, which may be sight threatening.

The recall includes all US Oftalmi over-the-counter eye drops and nasal drops including Camolyn Homeopathic eye drops, Camolyn Plus Naphazoline + Chamomile eye drops, Camolyn Refresh eye drops, Camolyn-A, Naphazoline + Pheniramine eye drops, and Fisolin nasal drops sodium chloride for pediatric uses. All products are packaged in 15 ml plastic bottles and were distributed nationwide to food and drug distributors for retail.

While a recall was initiated, US Oftalmi believes the risk of adverse reactions is remote. To date, no illnesses or injuries have been reported. The company has ceased production, importation and distribution of the products until further notice. Consumers who have the products are encouraged to discard them immediately. Consumers with questions may call US Oftaimi at (954) 338-6891 Monday through Friday 8AM to 4:30 PM EST.

Any adverse events or side effects with this or any other product should be reported to the FDA MedWatch Adverse Event Reporting program at www.FDA.gov/MedWatch.