Safety Report: LEADER OTC Ophthalmic Sterile Drops - recalled due to Insanitary manufacturing conditions, USA

United States

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. Products were distributed Nationwide to Wholesalers and Retailers starting December 12, 2021. To date, Cardinal Health, Inc., and its subsidiaries have received reports of three (3) adverse events related to these products. The reports of adverse events were shared with their supplier, Velocity Pharma, LLC.

The recalled products are:
- LEADER™ Eye Irritation Relief (Polyvinyl Alcohol, 0.5%, Povidone, 0.6%, and Tetrahydrozoline Hydrochloride, 0.05%), 0.5 FL OZ bottle (15 mL), NDC:
- LEADER™ Dry Eye Relief (Carboxymethylcellulose Sodium, 1%), 0.5 FL OZ bottle (15 mL), NDC: 70000-0089-1
- LEADER™ Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%), 0.5 FL OZ bottle (15 mL). NDC: 70000-0090-1
- LEADER™ Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%), 2 bottles, 0.5 FL OZ (15 mL) each. NDC: 70000-0090-2 (Carton) 70000-0090-1 (Bottle)
- LEADER™ Dry Eye Relief (Polyethylene Glycol 400, 0.4% and Propylene Glycol, 0.3%), 0.33 FL OZ bottle (10 mL), NDC: 70000-0088-1
- LEADER™ Lubricant Eye Drops (Propylene Glycol, 0.6%) 0.33 FL OZ bottle (10 mL), NDC:70000-0587-1

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.

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.

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 them to the place of purchase.

In case you experience harm from these products, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Cardinal Health, Inc.
Brand name: LEADER
Product recalled: OTC Ophthalmic Sterile Drops
Reason of the recall: Insanitary manufacturing conditions
FDA Recall date: November 01, 2023

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cardinal-health-inc-issues-voluntary-nationwide-recall-certain-leadertm-brand-eye-drops-supplied