Companies recall eye drops due to potential risk of infections

Eye drops recalls overview: 

• Who: Both Harvard Drug Group and Cardinal Health are recalling eye drops that came from Velocity Pharma LLC. 
• Why: Investigators from the U.S. Food and Drug Administration (FDA) found unsanitary conditions in the manufacturing facility and positive tests for bacteria.
• Where: The eye drops recalls are effective across the United States.

Both Harvard Drug Group and Cardinal Health are recalling eye drops that came from Velocity Pharma LLC after investigators from the U.S. Food and Drug Administration (FDA) found unsanitary conditions in the manufacturing facility and positive tests for bacteria.

The Harvard Drug Group, doing business as Major Pharmaceutical and Rugby Laboratories, issued a recall for all lots of its Polyvinyl Alcohol, 1.4% Lubricating Eye Drops and Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) that came from Velocity Pharma.

The Rugby Polyvinyl Alcohol has a National Drug Code (NDC) of 0536-1325-94 while the Rugby Lubricating Tears Eye Drops is 0536-1282-94.

The Cardinal Health recall includes the LEADER Eye Irritation Relief of 70000-0087-1, LEADER Dry Eye Relief of 70000-0089-1 and 70000-0088-1, LEADER Lubricant Eye Drops of 70000-0090-1, 70000-0090-2 and 70000-0587-1. 

Both recalls say the FDA tests showed positive bacterial test results from environmental sampling of critical drug production areas in the Velocity Pharma manufacturing facility.

Each company has received three reports of adverse effects from eye drops, recall says

Cardinal Health says it has received three reports of adverse effects related to the recall so far while Harvard Drug Group said it also has had three reports including reports of vision blurriness, vision loss and burning eyes. The companies are not currently facing legal action over the recall, but Top Class Actions follows recalls closely as they sometimes lead to class action lawsuits.

Distributors will be contacted directly by the companies about the eye drops infection risk and recall. Retailers should stop selling the eye drops and consumers should dispose of them.

Consumers can contact Sedgwick, Inc. related to the Cardinal Health recall at 855-215-4940 from 8 a.m. to 5 p.m. ET Monday through Friday or by email at [email protected]. Harvard Drug Group customers can contact Sedgwick, Inc. by phone at 866-891-1981 from 8 a.m. to 5 p.m. ET Monday through Friday or by email at [email protected].

CVS Pharmacy Inc. was accused of falsely advertising its homeopathic pink eye drops product as safe and effective even though it is allegedly not capable of delivering the promised results in a class action lawsuit filed Sept. 17 in New York federal court.

Are you affected by the eye drops recalls? Let us know in the comments. 

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