Systane Ultra PF voluntary recall: Protecting patients from potential risk of fungal material in one lot

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In response to a report of foreign material found in a sealed vial, Alcon Laboratories has initiated a voluntary recall of Lot 10101 of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count. Alcon evaluated a consumer complaint of foreign material observed inside a sealed single use vial and determined the material to be fungal in nature.

The company issued the following a 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.”

To date, Alcon Laboratories has not received any reports of adverse events related to this recall. 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 colour design, presence of “Systane” and “ULTRA PF” brand names on the front of the carton, and the “25 vials” package size.

Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101) was distributed nationwide in the United States to retail and internet outlets. Consumers with 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.

Consumers with questions regarding this recall can contact Alcon Laboratories at 800-241-5999 between 7:30am and 6:00pm (Central), Monday to Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product. Alcon Laboratories is notifying its distributors and customers by letter, email, and/or phone call and is arranging for replacement of all recalled products.

Distributors or retailers should discard any remaining stock of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101).

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report online
• Regular mail or fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 800-FDA-0178.

This recall is being conducted with the knowledge of the US FDA.

Reference

1. Alcon Laboratories issues voluntary nationwide recall of one (1) lot of Systane lubricant eye drops Ultra PF, single vials on-the-go, 25 count (Lot 10101), due to fungal contamination. News release. Alcon. December 21, 2024. Accessed December 27, 2024. https://www.fda.gov/safety/recalls-markt-withdrawals-safety-alerts/alcon-laboratories-issues-voluntary-nationwide-recall-one-1-lot-systane-lubricant-eye-drops-ultra-pf