Systane Lubricant Eye Drugs - recalled due to Fungal Contamination, USA

United States

Alcon Laboratories is voluntarily recalling one (1) lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count to the consumer level. Alcon evaluated a consumer complaint of foreign material observed inside a sealed single use vial and determined the material to be fungal in nature. Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101) was distributed nationwide to retail and internet outlets.

Risk Statement: Fungal contamination of an ophthalmic product is known to potentially cause eye infections. If an infection occurs, it may be vision-threatening, and in very rare cases potentially life-threatening in immunocompromised patients.

Systane Lubricant Eye Drops Ultra PF is used for the temporary relief of burning and irritation in persons experiencing dry eye symptoms and is packaged in a cardboard carton containing 25 sterile, single-use LDPE plastic vials of preservative free solution for ophthalmic use (NDC 0065-1432-06, UPC 300651432060). The affected Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count is limited to lot number 10101, expiration date 2025/09. The product can be identified by the green and pink carton design, presence of "Systane" and "ULTRA PF" brand names on the front of the carton, and the "25 vials" package size.

Consumers that have the recalled Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101) which is being recalled should stop using them immediately and return to the place of purchase for a replacement or refund.

Company name: Alcon Laboratories
Brand name: Systane
Product recalled: Lubricant Eye Drugs
Reason of the recall: Due to Fungal Contamination
FDA Recall date: December 23, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/alcon-laboratories-issues-voluntary-nationwide-recall-one-1-lot-systane-lubricant-eye-drops-ultra-pf