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| The United States: The Harvard Drug Group, LLC issues voluntary nationwide recall of certain Rugby® Laboratories brand eye drops supplied by Velocity Pharma, LLC due to potential risk of eye infections (English only) |
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The US Food and Drug Administration (FDA) announces that the Harvard Drug Group, LLC d/b/a Major® Pharmaceutical and Rugby® Laboratories is initiating a voluntarily 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.
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 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 the supplier, Velocity Pharma, LLC.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/harvard-drug-group-llc-issues-voluntary-nationwide-recall-certain-rugbyr-laboratories-brand-eye
In Hong Kong, the above products are not registered pharmaceutical products. Related news was previously issued by FDA, and was posted on the Drug Office website on 28 Oct 2023.
Ends/Thursday, Nov 2, 2023
Issued at HKT 16:00
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