Multiple Brands of Eye Drops Recalled Due to Infection Risks

Following an eye drop contamination warning issued weeks ago by federal regulators, Kilitch Healthcare India Limited has recalled 27 different over-the-counter eye drop products sold under several popular brand names, including Target, CVS, Rite Aid, and Walmart, which may pose serious eye infection risks due to bacterial contamination.

The U.S. Food and Drug Administration (FDA) announced the Kilitch Healthcare India Limited eye drop recall on November 15, after agency investigators discovered unsanitary conditions in the manufacturing facility, and sample testing identified bacteria in critical drug production areas.

As a result of the positive bacterial test results from the production site, the manufacturer has removed all lots of its eye drop products from the market. While the manufacturer indicates that it is not aware of any adverse events or reactions in relation to the contamination issue, two distributors reported they received at least six complaints from consumers who experienced eye complications or injuries after using the products.

Eye Drop Warning

The recall follows an FDA advisory issued on October 27, which warned consumers that more than two dozen different over-the-counter eye drop products sold under several well-known brand names, including CVS, Target, and Rite Aid may contain harmful bacteria that could cause severe eye infections, and potentially result in vision loss or permanent blindness.

Officials recommended the manufacturer issue a recall, after sample testing determined Kilithch Healthcare India Limited’s manufacturing facility was unsterile and contained bacteria that posed vison-threatening infection risks to consumers. The site produced dozens of different eye drop products for Velocity Pharma, LLC, who then supplied them to several distributors.

The agency indicated that CVS, Rite Aid, and Target were removing the products from store shelves and websites; however, it warned consumers to avoid those distributed under Leader, Rugby, and Velocity brands, as they were still available for purchase. The FDA updated the eye drop warning list on October 30 to include Equate Hydration PF Lubricant 10 ml eye drops, and indicated Walmart was removing them from its stores and website as well.

Kilitch Healthcare India Limited Eye Drop Recall

The manufacturer issued a recall of all over-the-counter eye drop products intended to relieve dry eyes or irritation following the FDA recommendation. The recall impacts eye drop products produced for Velocity Pharma, which were then supplied to several distributors and sold under different brand names, including Walmart, Target, CVS, Rite Aid, Rugby, Leader, and Velocity.

Kilitch Healthcare India Limited indicates that it was notifying Velocity Pharma of the recall, who will then notify wholesalers and retailers.

Consumers should immediately stop using the recalled eye drops and return them to their original place of purchase for a full refund. The recall also urged consumers to contact their healthcare provider if they experience any issues that may be related to use of the product.

For more information on the recall, consumers may email regulatory@velocitypharma.com or regulatory@kilitchhealthcare.com.

The FDA also urges consumers to report any adverse reactions or quality issues they experienced after using the products to the FDA MedWatch Adverse Event Reporting Program.

Eye Drop Contamination Concerns

In September, the FDA issued warning letters over concerns of dangerous eye drops to CVS, Boiron, DR Vitamin Solutions, OcluMed, Similasan and TRP Company in September over manufacturing violations, dangerous ingredients, contamination concerns, and some were not approved by the agency, or were illegally marketed to treat serious eye conditions.

A month earlier, a Dr. Bernes and LightEyez MSM eye drops recall issued in August, due to bacterial and fungal contamination, after at least one lot of the recalled products were found to be tainted with several strains, and contained the unapproved and illegally marketed ingredient, methylsulfonylmethane (MSM). At least two consumers reported an adverse event in relation to the eye drops, which ranged from minor eye infections to serious blood stream infections.

Cardinal Health, Inc. recalled multiple eye drop products sold under the brand name Leader on November 1, and indicated it had received at least three complaints from consumers who experienced an adverse reaction or event after using the products. The recall impacted all lots of over-the-counter eye drops supplied by Velocity Pharma that were distributed nationwide since December 12, 2021.

Harvard Drug Group, LLC issued a recall of certain eye drop products sold under the brand name Rugby on the same day, and indicated it had become aware of at least three consumers who experienced an adverse reaction events after using the eye drops, which resulted in eye burning, blurry vision, and even vision loss. The Rugby recall impacted all lots of its lubricating eye drop products supplied by Velocity Pharma that were distributed nationwide starting June 1, 2021.

Artificial Tears Eye Drop Infection Lawsuits

Concerns were primarily sparked by an Artificial Tears eye drop recall issued in February, after a massive eye infection outbreak was linked to the contaminated products, including Delsam Pharma and EzriCare eye drops.

The products were found to contain Carbapenem-Resistant Pseudomonas Aeruginosa (CRPA), a bacterial strain known to cause infections that may result in severe health consequences, due to its antibiotic resistance and mutating capabilities. In severe cases, the bacteria can cause endophthalmitis, a rare but serious eyeball infection that can destroy eye tissue and cause irreversible blindness.

The recalled artificial tear eye drops have been linked to at least 81 case of bacterial contamination, according to the CDC, which includes multiple reports of vision loss, at least four reports of eyeball removal, and at least four deaths.

A growing number of consumers are pursuing Artificial Tears lawsuits, alleging that bacteria in the eye drops caused a wide range of health problems, including vision loss, eye infections, bloodstream infections and other injuries.