TOPIC: Certain Eye Drops by Rugby Laboratories: Recall - Due to Potential Risk of Eye Infections
AUDIENCE: Consumer, Health Professional, Ophthalmology, Pharmacy
ISSUE: The Harvard Drug Group, d/b/a Major Pharmaceutical and Rugby Laboratories is recalling all lots of Polyvinyl Alcohol, 1.4% Lubricating Eye Drops and Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) supplied by Velocity Pharma, because the Harvard Drug Group received information from FDA indicating the 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.
The Harvard Drug Group has received three (3) reports of adverse events related to these products including reports of vision blurriness, vision loss, and burning eyes. The reports of adverse events were shared with our supplier, Velocity Pharma. Products were distributed Nationwide starting June 1, 2021.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: Polyvinyl Alcohol, 1.4% Lubricating Eye Drops and Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) are available as over the counter (OTC) products used for temporary relief or discomfort due to minor irritations of the eye or to exposure to wind or sun and the product used as a protectant against further irritation or to relieve dryness of the eye.
RECOMMENDATIONS:
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Consumers should stop using the recalled eye drop products and may return them to the place of purchase.
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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.
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Consumers with questions regarding this recall can contact the company.
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Wholesalers, Distributors and Retailers that have the affected product which is being recalled should cease distribution of the products.
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