U. S. Food and Drug Administration
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.
Cardinal Health, Inc. Issues Voluntary Nationwide Recall of Certain LEADER™ Brand Eye Drops Supplied by Velocity Pharma, LLC Due to Potential Risk of Eye Infections
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company’s announcement as a public service. FDA does not endorse either the product or the company.
Summary
Company Announcement Date: October 31, 2023 FDA Publish Date: November 01, 2023 Product Type: Drugs Reason for Announcement:
Company Announcement
FOR IMMEDIATE RELEASE – October 31, 2023 – Dublin, OH, Cardinal Health, Inc. is initiating a voluntarily recall for all lots of ophthalmic products supplied by Velocity Pharma, LLC to the consumer level. Cardinal Health, Inc. received information from FDA indicating investigators found insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility.
Risk Statement: For those patients who use these products, there is a potential risk of eye infections that could result in partial vision loss or blindness. These products are intended to be sterile. Ophthalmic drug products pose a potential heightened risk of harm to users because drug applied to the eyes bypass some of the body’s natural defenses. To date, Cardinal Health, Inc., and its subsidiaries have received reports of three (3) adverse events related to these listed products. The reports of adverse events were shared with our supplier, Velocity Pharma, LLC.
These products are available as over the counter (OTC) products used for temporary relief of burning and irritation due to dryness of the eye, for use as a protectant against further irritation or to relieve dryness of the eye, and/or to relieve redness of the eye due to minor eye irritations.
These products can be identified on the outer carton labeling as follows:
| Product Name | Package Description |
Brand Name |
NDC |
|---|---|---|---|
| Eye Irritation Relief (Polyvinyl Alcohol, 0.5%, Povidone, 0.6%, and Tetrahydrozoline Hydrochloride, 0.05%) |
0.5 FL OZ bottle (15 mL) |
LEADER™ | 70000-0087-1 |
| Dry Eye Relief (Carboxymethylcellulose Sodium, 1%) |
0.5 FL OZ bottle (15 mL) |
LEADER™ | 70000-0089-1 |
| Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%) |
0.5 FL OZ bottle (15 mL) |
LEADER™ | 70000-0090-1 |
| Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%) |
2 bottles, 0.5 FL OZ (15 mL) each |
LEADER™ | 70000-0090-2 (Carton) 70000-0090-1 (Bottle) |
| Dry Eye Relief (Polyethylene Glycol 400, 0.4% and Propylene Glycol, 0.3%) |
0.33 FL OZ bottle (10 mL) |
LEADER™ | 70000-0088-1 |
| Lubricant Eye Drops (Propylene Glycol, 0.6%) |
0.33 FL OZ bottle (10 mL) |
LEADER™ | 70000-0587-1 |
Images of the outer carton labeling of these listed products can be found below.
Products were distributed Nationwide to Wholesalers and Retailers starting December 12, 2021.
Cardinal Health, Inc. is notifying all impacted direct accounts via mail of this voluntary recall and is arranging for return of all recalled products listed above. Wholesalers, Distributors and Retailers that have the affected product which is being recalled should cease distribution of the products. Consumers should stop using the recalled eye drop products and may return any of the above listed products to the place of purchase.
Consumers with questions regarding this recall can contact Sedgwick, Inc. by phone at 1-855-215-4940 (8:00am-5:00pm EST Monday through Friday) or by email at [email protected]. Consumers 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.
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:www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
FDA warns consumers not to purchase or use certain eye drops from several major brands due to risk of eye infection
[11/3/2023] Cardinal Health Inc. has initiated a voluntarily recall for all lots of six Leader brand ophthalmic products. The list FDA provided on October 27 included five products branded as Leader. The list has been updated to include the sixth product.
Additionally, Harvard Drug Group LLC also initiated a voluntary nationwide recall for all lots of two Rugby Laboratories brand eye drops.
The agency has updated the list of products to include the national drug codes (NDCs) that have been confirmed. FDA will provide additional information as it becomes available.
[10/30/2023] FDA is updating the list of over-the-counter eye drop products consumers should not purchase or use to include Equate Hydration PF Lubricant Eye Drop 10 mL sold by Walmart in stores and online. Walmart is removing the product from their store shelves and website.
[10/27/2023] 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. 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. These products are marketed under the following brands:
- CVS Health
- Leader (Cardinal Health)
- Rugby (Cardinal Health)
- Rite Aid
- Target Up and Up
- Velocity Pharma
These products are intended to be sterile. Ophthalmic drug products pose a potential heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses.
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. FDA also recommends consumers properly discard these products.
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.
FDA has not received any adverse event reports of eye infection associated with these products at this time. FDA encourages health care professionals and patients to report adverse events or quality problems with any medicine to FDA’s MedWatch Adverse Event Reporting program:
- Complete and submit the report online at Medwatch; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.