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FDA recalls eye drops due to potential fungal contamination

The eye drops are intended for temporary relief of burning and irritation for people experiencing dry eye symptoms.
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A popular brand of eye drops is now being recalled nationwide due to a possible fungal contamination. Alcon Laboratories in Texas is voluntarily recalling Systane Lubricant Eye Drops Ultra P-F, the Food and Drug Administration announced.

The FDA said the recall was initiated after Alcon evaluated a consumer complaint of foreign material observed inside a sealed single-use vial and determined the material to be fungal in nature. There have been no reported injuries associated with recalled eye drops.

Fungal contamination in eye drops can cause eye infections, which can threaten vision. If you have these eye drops, stop using them and return them for a full refund.

"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," the FDA said.

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The eye drops are intended for temporary relief of burning and irritation for people experiencing dry eye symptoms.

Affected products are 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 FDA said packages 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.

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