A recall of all Camolyn Eye Drops and Fisiolin Nasal Drops has been issued after it was discovered that they may not be sterile, which could cause infections or blindness.
The nasal and eye drop recall was announced on Wednesday by FDA. According to a press release from the manufacturer, US Oftalmi Corporation, the recall was initiated after it was determined that conditions in the manufacturing facility could not guarantee the sterility of the drops. However, there have been no injuries or reports of problems from consumers.
The Camolyn Eye Drops recall and Fisiolin Nasal Drops recall affects all over-the-counter drops under those labels, including Camolyn Homeopathic; Camolyn Plus, Naphazoline + Chamomile; Camolyn Refresh; Camolyn-A, Naphazoline + Pheniramine; and Fisiolin Nasal Drops Sodium Chloride Pediatric Uses. All of the recalled eye drops and nasal drops were distributed nationwide to food and drug distributors and were packaged in 15 mL plastic bottles.
If a consumer uses non-sterile drops, they could develop an infection. Some eye infections could potentially lead to blindness. However, US Oftalmi has said that it believes the likelihood of users experience a severe adverse reaction is remote.
The company has ceased production of the nasal and eye drops until the manufacturing problem can be solved. It is recommended that any consumers with the recalled eye and nasal drops discard them immediately.
Anyone who experiences an adverse reaction from this product should report the incident to the FDA’s MedWatch Program at www.fda.gov/medwatch.