FDA Announces Kilitch Healthcare India Eyedrop Recall

On November 15, 2023, the United States Food and Drug Administration published a voluntary recall statement from Kilitch Healthcare India Limited for 27 eyedrops distributed across the US through multiple retailers, including Rugby, Target, Rite Aid, Leader, Velocity, CVS, and Walmart.

According to the manufacturer’s recall statements, the expiration date on these products ranged from November 2023 to September 2025.

Previously, on October 27, 2023, the FDA issued warnings to consumers regarding these products, revealing that using these over-the-counter eyedrops could cause eye infections, resulting in partial or total vision loss.

Since the warning letters were issued, multiple retailers and distributors have responded by removing the products from their shelves and issuing voluntary recalls. For example, CVS, Rite Aid, and Target almost immediately told the FDA they would remove the products from stores and their websites.

Four days after the warning letters were released, Cardinal Health and the Harvard Group LLC issued voluntary nationwide recalls on the affected products listed.

In Cardinal Health’s recall statement, the organization revealed the supplier for their products, namely, the Leader brand eyedrops, was Velocity Pharma. Additionally, an article from the Washington Post implied that all the recalled products were distributed to retailers or sold directly by Velocity Pharma, confirmed by Kilitch’s recall statement.

The Harvard Group’s recall applied to eye drops sold under Rugby Laboratories and cited unsanitary manufacturing conditions as the primary cause of the recall. Kilitch’s statement verified this claim by noting that FDA investigators found unsanitary conditions.

Unsanitary manufacturing is not a new concern on the hefty list of eyedrops recalled throughout this year. A previous FDA investigation following a recall of artificial tears manufactured by Global Pharma Healthcare, another manufacturer based in India, revealed multiple sanitation concerns and violations of current good manufacturing practices (CGMP). A thorough analysis and publicly released document identified 19 breaches of mandatory quality control tests, dirty equipment, contaminated containers, and inefficient filtering tools.

Although the FDA has not concluded or revealed its investigation into Kilitch Healthcare India, the implications of unsanitary conditions threaten the health and safety of patients using their products. 

The broader concern is why the list of recalls continues to grow exponentially despite available CGMP guidelines to inform sanitation practices. The ongoing recalls point to a potential issue in standard operating procedures for eye drop manufacturers.

Moreover, these concerns pose questions about the FDA’s foreign manufacturing oversight protocols.

As Kilitch notifies its distributor, Velocity Pharma, and the distributor notifies its wholesalers and retailers, the products should be removed from the retail market. Meanwhile, patients and providers should be vigilant about the types of over-the-counter eyedrops they use or recommend.