Voluntary nationwide recall: Systane (Alcon – December)
Alcon Laboratories is recalling one lot, lot 10101, of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go. Systane Lubricant Eye Drops. Ultra PF is used for the temporary relief of burning and irritation in persons with dry eye symptoms.
This drug is being recalled because Alcon evaluated a consumer complaint of foreign material observed inside a sealed single-use vial and determined the material to be fungal in nature. Using an eye product that contains fungal material may cause eye infections. These eye infections could be vision-threatening or life-threatening in people with weakened immune systems.
To see if your medication was recalled, contact your doctor or pharmacy where you received it or visit the FDA website below. If you have an affected lot of Systane, you should stop using the product and return it to the place of purchase for a replacement or refund.
As of Dec. 23, there had been no reports of adverse events related to this recall.
To learn more about this recall, you can take one or more of the steps below.
- Talk to your doctor or pharmacist.
- Call Alcon Laboratories at 1-800-241-5999. TTY users should call 711. Help is available Monday through Friday from 7:30 a.m. to 6 p.m. CST.
- Visit the FDA website.