Safety Report: Rugby OTC Ophthalmic Sterile Drops - recalled due to Insanitary manufacturing conditions, USA

United States

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. Products were distributed Nationwide starting June 1, 2021. 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 their supplier, Velocity Pharma, LLC.

The recalled products are:
- Rugby® Polyvinyl Alcohol, 1.4% Lubricating Eye Drops, 0.5 oz bottle (15 mL). NDC: 0536-1325-94
- Rugby® Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%), 0.5 oz bottle (15 mL). NDC: 0536-1282-94

These products 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 is used as a protectant against further irritation or to relieve dryness of the eye.

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.

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 them to the place of purchase.

In case you experience harm from these products, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: The Harvard Drug Group, LLC dba Major Pharmaceutical and Rugby Laboratories
Brand name: Rugby
Product recalled: OTC Ophthalmic Sterile Drops
Reason of the recall: Insanitary manufacturing conditions
FDA Recall date: November 01, 2023

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/harvard-drug-group-llc-issues-voluntary-nationwide-recall-certain-rugbyr-laboratories-brand-eye