Drug Recall: OTC Eye Drops
StayWell Insurance | November 02, 2023 | Maite, GU
Dear Prescriber:
Various brands are initiating voluntary recalls for all lots of over-the-counter (OTC) eye drops supplied by Velocity Pharma, LLC to the consumer level. The FDA sent information to these brands indicating their investigator 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. There are reports of adverse events related to these listed products, including reports of vision blurriness, vision loss, and burning eyes.
These products are available as 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 are marketed under the following brands:
| Brand | Product | NDC # |
|---|---|---|
| Leader | Eye Irritation Relief (Polyvinyl Alcohol, 0.5%, Povidone, 0.6%, and Tetrahydrozoline Hydrochloride, 0.05%) | 70000-0087-1 |
| Leader | Dry Eye Relief (Carboxymethylcellulose Sodium, 1%) | 70000-0089-1 |
| Leader | Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%) | 70000-0090-1 |
| Leader | Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%) | 70000-0090-2 |
| Leader | Dry Eye Relief (Polyethylene Glycol 400, 0.4% and Propylene Glycol, 0.3%) | 70000-0088-1 |
| Leader | Lubricant Eye Drops (Propylene Glycol, 0.6%) | 70000-0587-1 |
| Leader | Polyvinyl Alcohol, 1.4% Lubricating Eye Drops | 00536-1282-94 |
| Leader | Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) | 00536-1325-94 |
Brands are 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.
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:
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Complete and submit the report Online: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
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Regular Mail or Fax: Download form https://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