WASHINGTON (dpa-AFX) - Fort Worth, Texas-based Alcon Laboratories, affiliated to Swiss eye care device firm Alcon Inc., is recalling one lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count.
According to the US Food and Drug Administration or FDA, a sealed single-use vial was found to contain a foreign substance, which was identified as a type of fungus.
The recall to the consumer level is limited to lot number 10101 with an expiration date of 2025/09.
The recalled product is used for the temporary relief of burning and irritation caused by dry eyes.
The impacted product can be identified by the green and pink carton design. It comes in a cardboard box with 25 sterile, single-use plastic vials containing a preservative-free solution for eye use with NDC 0065-1432-06, UPC 300651432060.
The products were distributed nationwide to retail and internet outlets.
The eye drops were recalled following a consumer complaint of foreign material observed inside a sealed single use vial that was found to be fungal contamination, which can cause eye infections. These infections could harm vision and, in very rare cases, may be life-threatening for patients with weakened immune systems.
However, the company has not received any reports of adverse events related to the recall.
Consumers are asked to stop using them immediately and return to the place of purchase for a replacement or refund.
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