Last Updated on December 31, 2023 by The Health Master
Drug recall
La Vergne, TN, The Harvard Drug Group, LLC d/b/a Major® Pharmaceutical and Rugby® Laboratories is initiating a voluntarily drug recall for 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, LLC to the consumer level.
The Harvard Drug Group, LLC received information from FDA indicating 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 of 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, LLC 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, LLC.
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 of 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.
Batches recalled
Both Polyvinyl Alcohol, 1.4% Lubricating Eye Drops and Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) can be identified on the outer carton labeling as follows:
| Brand Name | Product Name | Package Description | NDC |
|---|---|---|---|
| Rugby® | Polyvinyl Alcohol, 1.4% Lubricating Eye Drops | 0.5 oz bottle (15 mL) | 0536-1325-94 |
| Rugby® | Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) | 0.5 oz bottle (15 mL) | 0536-1282-94 |
Products were distributed Nationwide starting June 1, 2021.
The Harvard Drug Group, LLC 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.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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