United States (U.S.) Food and Drug Administration (FDA) Recall of Contaminated Eye Drops

November 1, 2023 | by sau1admin

The Office of Developmental Programs (ODP) is sharing this important information about eye drops from the U.S. FDA. Eye drops from the 26 products listed below in the FDA MedWatch warning should not be used.

TOPIC: FDA is warning consumers not to purchase and to immediately stop using 26 over-the-counter eye drop products due to the potential risk of eye infections that could result in partial vision loss or blindness.

AUDIENCE: Consumer, Health Professional, Ophthalmology

ISSUE: FDA recommended the manufacturer of these products recall all lots on October 25, 2023, after agency investigators found insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility.

CVS, Rite Aid and Target are removing the products from their store shelves and websites. Products branded as Leader, Rugby and Velocity may still be available to purchase in stores and online and should not be purchased.

Risk Statement: Using contaminated eye drops could result in minor to serious vision-threatening infection which could possibly progress to a life-threatening infection. To date, there have been no reports of adverse events related to this recall.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: These products are used as a lubricating eye drops.

RECOMMENDATIONS:

• Patients who have signs or symptoms of an eye infection after using these products should talk to their health care provider or seek medical care immediately.
• Consumers/distributors/retailers that have product which is being recalled should stop using and dispose of them immediately.
  
• The best way to dispose of most types* of unused or expired medicines (both prescription and over the counter) is to drop off the medicine at a drug take back site, location, or program immediately.
• If you cannot get to a drug, take back location promptly, or there is none near you, and your medicine is
  
  • on the FDA flush list, your next best option is to immediately flush these potentially dangerous medicine down the toilet.
  • not on the flush list, you should follow these instructions to discard the medicine in your trash at home.

Health professionals and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

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

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