Systane drops recalled over fungal risk

Alcon Laboratories recalled one lot of Systane Lubricant Eye Drops Ultra PF after it identified fungal material in a sealed single-use vial. (fda.gov) The recall applies to Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count, lot 10101, with expiration date 2025/09. The product was distributed nationwide to retail stores and internet outlets. (fda.gov) Alcon said it investigated a consumer complaint about foreign material inside an unopened vial and determined the material was fungal in nature. The company said the recall is being conducted with the knowledge of the Food and Drug Administration. (fda.gov) (contagionlive.com) Eye drops are meant to be sterile, which means free of bacteria, fungi, or other organisms before they touch the eye. When a contaminated product is placed directly on the eye, it can cause infection because the surface is exposed and sensitive. (fda.gov) Alcon said fungal contamination of an ophthalmic product is known to potentially cause eye infections. The company said people who have the recalled drops should stop using them immediately and return them to the place of purchase for a replacement or refund. (fda.gov) The recalled cartons can be identified by the green-and-pink box design, the Systane and Ultra PF branding on the front, and the 25-vial package size. The package carries National Drug Code 0065-1432-06 and Universal Product Code 300651432060. (fda.gov) Alcon said it was notifying distributors and customers by letter, email, or phone and arranging replacement of recalled products. Retailers and distributors were told to discard any remaining stock from the affected lot. (fda.gov) The Food and Drug Administration notice said no adverse events had been reported at the time of the recall. People who experienced problems related to the drops were told to contact a physician and report events to the agency’s MedWatch program. (fda.gov) For users, the practical check is narrow: Systane Ultra PF in 25-count single-use vials is affected only if the carton is lot 10101 and expires in September 2025. Everyone else is being told to match the lot number before stopping use. (fda.gov)