The Harvard Drug Group, LLC complied with a request by the FDA and undertook a voluntary nationwide recall of certain Rugby Laboratories Brand Eye Drops that were supplied by Velocity Pharma, LLC, because of a potential risk of eye infections. This recall was initiated by The Harvard Drug Group, LLC d/b/a Major® Pharmaceutical and Rugby® Laboratories in response to identified concerns regarding the safety of the products supplied by Velocity Pharma, LLC .
The risk associated with these eye drops lies in the potential for eye infections that could lead to partial vision loss or even blindness for individuals who use these affected products. Several adverse events have been reported, including vision blurriness, vision loss, and burning eyes, prompting The Harvard Drug Group, LLC to take this precautionary recall action.
It is to be noted that the Harvard Drug Group, LLC has received three reports of adverse events related to these products including reports of vision blurriness, vision loss, and burning eyes.
The specific products subject to this recall are Polyvinyl Alcohol, 1.4% Lubricating Eye Drops and Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%), which are over-the-counter (OTC) items used for providing temporary relief in cases of minor eye irritations from environmental exposure like wind or sun, along with eye protection from further irritation or dryness.
Identified by the brand name Rugby®, these products can be recognized by their outer carton labeling information:
- Rugby® Polyvinyl Alcohol, 1.4% Lubricating Eye Drops in a 0.5 oz bottle (15 mL)
- Rugby® Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) in a 0.5 oz bottle (15 mL)
It is crucial to note that the recalled eye drop products were distributed nationwide starting from June 1, 2021. Consumers who have purchased these items are advised to discontinue their use immediately and return them for proper handling.