The Harvard Drug Group Recalls Rugby Laboratories Brand Eye Drops Supplied by Velocity Pharma
Medical Recalls
Lubricating Eye Drops
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 investigators 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.
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 below. 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 below listed products to the place of purchase.
Source and more information: FDA
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Consumer Contact: -
Consumers with questions regarding this recall can contact Sedgwick, Inc. by phone at 1- 866-891-1981 (8:00am-5:00pm EST Monday through Friday) or by email address harvarddrug8430@sedgwick.com. 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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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 |
Report a Problem With This Product
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
- Complete a paper Voluntary MedWatch form that can be mailed to the FDA.
- https://www.fda.gov/safety/report-problem-fda
- Call an FDA Consumer Complaint Coordinator.
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This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.
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This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.
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