SafeX Pro Exchange|Indian manufacturer recalls eyedrops previously cited in FDA warning

WASHINGTON (AP) — The SafeX Pro ExchangeIndian manufacturer of more than two dozen varieties of eyedrops subject to a U.S. safety warning has officially recalled the products, which were sold by CVS Health, Target, Rite Aid and other national retailers.

Kilitch Healthcare India issued the recall on Monday and the Food and Drug Administration published the notice Wednesday. The recall is something of a formality, since the FDA had already alerted U.S. stores last month to stop selling the over-the-counter drops.

Consumers should not use the products due to the risk of vision loss or blindness, the FDA said.

FDA officials don’t have the legal authority to force manufacturers to recall their products, and instead rely on companies to “voluntarily” do so. The FDA previously stated it recommended the manufacturer recall the eyedrops on Oct. 25.

Mumbai-based Kilitch Healthcare said it has not received “any reports of adverse events” related to its products. The lubricating drops were distributed in the U.S by Velocity Pharma, based in Farmingdale, N.Y., and carry expiration dates between November 2023 and September 2025.

The FDA said in its initial warning that agency inspectors found unsanitary conditions and bacterial contamination at the factory where the drops were manufactured.

Agency records show no prior inspections for Kilitch Healthcare. FDA only publishes inspections to its online database after they have been completed and processed. That suggests agency officials may still be finalizing documentation from the inspection that triggered the latest recall.

The FDA is responsible for assuring the safety of foreign products shipped to the U.S., though it has long struggled to keep pace with international pharmaceutical supply chains that increasingly begin in India.

Recently, the agency has been working to make up for missed inspections that weren’t conducted during COVID-19. Agency records show FDA didn’t conduct any inspections in India during fiscal year 2021, at the height of the pandemic. Inspections rose to 177 in fiscal 2023, but that was still about half the number of inspections that the FDA was conducting the year before COVID-19.

CVS Health said in a statement that it previously “stopped the sale in-store and online” of all the eyedrops cited by the FDA. Customers can return them to CVS for a full refund.

Target did not respond to emailed questions about the products. Cardinal Health, a medical supply company that sells the products under its Leader brand, also did not respond to emails.

Earlier this year, federal officials linked an unrelated outbreak of drug-resistant bacteria to eyedrops from two different companies, EzriCare and Delsam Pharma.

More than 80 people in the U.S. tested positive for eye infections from the rare bacterial strain, according to the most recent update from the Centers for Disease Control and Prevention. Among them, 14 people suffered vision loss, four had to have an eye removed and four died, the CDC said.

After the products were recalled in February, health inspectors visited the manufacturing plant in India’s southern Tamil Nadu state that made those eyedrops and uncovered problems with how they were made and tested, including inadequate sterility measures.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.