Eye Drops Recalled Due To Possible Risk Of Partial Vision Loss, Blindness

There is a voluntary recall for all lots of Polyvinyl Alcohol, 1.4% Lubricating Eye Drops and Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) sold to consumers across the nation. For anyone who uses these products, there is a potential risk of eye infections that could result in partial vision loss or blindness, the FDA said.

The following products, which come in 0.5 ounce (15 mL) bottles, are being recalled:

• Rugby Polyvinyl Alcohol, 1.4% Lubricating Eye Drops, which have the code 0536-1325-94.

 

• Rugby Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%), 0536-1282-94.

The Harvard Drug Group, LLC, which does business as Major Pharmaceutical and Rugby Laboratories, is initiating the recall after receiving information from the FDA after insanitary conditions were discovered in the manufacturing facility. According to a FDA press release, positive bacterial test results from environmental sampling of critical drug production areas in the facility.

The 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. Harvard Drug Group has received three 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 Velocity Pharma.

Polyvinyl Alcohol, 1.4% Lubricating Eye Drops and Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) are available as over the counter 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, according to the FDA.

Harvard Drug Group 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.

Consumers with questions regarding this recall can contact Sedgwick, Inc. by phone at 1-866-891-1981 (8 a.m. to 5 p.m. Monday through Friday) or by email at [email protected]. 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.
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 at www.fda.gov/medwatch/report.htm

• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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.