Consumer Watchdog

Eye drops manufacturer finally recalls dangerous eye drops; FDA couldn’t do it

FDA warned products could cause blindness, but the regulator can't issue mandatory recalls for most over-the-counter health products

Courtesy of FDA | Public Domain

Three weeks after the U.S. Food and Drug Administration (FDA) warned consumers that 27 types of eye drops could cause blindness, the overseas manufacturer has agreed to a recall. Kilitch Healthcare India Limited this week issued a voluntary recall of all of the types of eye drops targeted by the FDA starting on Oct. 27.

The eye drops “are being recalled due to potential safety concerns after FDA investigators found insanitary conditions,” according to the announcement from the FDA. They were distributed nationwide to wholesalers and retailers through Velocity Pharma LLC.

The eye drops, often used to treat eye dryness, were sold under different private labels through CVS Health, Rite Aid, Target Up&Up, Equate (Walmart,) Velocity Pharma and Leader and Rugby, both of which come from Cardinal Health.

The FDA doesn’t have the authority to issue mandatory recalls of over-the-counter medications; bills have been introduced in Congress to change this. The FDA does have mandatory recall authority over dietary supplements, cosmetics and products including medical devices, vaccines and nicotine products.

This warning follows three separate recalls of eye drops this year. One was linked to stemming from drug-resistant bacteria. One was linked to 81 incidents, including four deaths and 14 cases of vision loss, the FDA and Centers for Disease Control and Prevention said. Contaminated products that people put in their eyes are especially dangerous because that delivery method can “bypass some of the body’s natural defenses,” the FDA said.

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