STATEMENT: FDA warns public about 27 brands of eye drops; agency needs mandatory recall authority

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WASHINGTON – Nearly nine months after a major recall involving eye drops linked to four deaths and 14 cases of vision loss, the U.S. Food and Drug Administration (FDA) is advising consumers not to use 27 different brands of over-the-counter eye drops. The FDA says that using the eye drops, which generally treat dry eyes, could lead to blindness.

The FDA says the products are from one manufacturer and are sold under the brands CVS Health, Rite Aid, Target Up&Up, Equate, Velocity Pharma and Leader and Rugby, both of which come from Cardinal Health. The FDA asked the manufacturer to recall all of the affected eye drops on Oct. 25, but according to the FDA website, as of Monday afternoon, that hadn’t happened yet. So, consumers may still find some of the drops for sale. FDA investigators said they found “insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas.” CVS, Rite Aid and Target agreed to stop selling the products last week; the Equate brand was added Monday and Walmart agreed to pull the products. The other brands may still be available, the FDA 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. No injuries connected to these 26 products have been reported yet.

In response, Teresa Murray, U.S. PIRG Education Fund Consumer Watchdog, said:

“This is infuriating, for a few reasons: First, prior to this FDA warning, there have been three major eye drop recalls this year for bacterial contamination or unsterile products. Why has it taken this long for the FDA to discover this much broader problem?

“Second, this points to the need for the FDA to have authority to recall unsafe prescriptions and over-the-counter medications when companies — for example, this eye drop manufacturer — refuse to cooperate in a timely fashion. Over the last few years, Congress has considered at least two bills — the Protecting Americans from Unsafe Drugs Act and the Recall Unsafe Drugs Act, now part of another bill — that would give the FDA mandatory recall authority. Neither has passed yet.

“Third, antibiotic overuse is a primary driver of drug-resistant bacteria —  the cause of the eye drop contamination earlier this year. We need to address antibiotic overuse to protect people against a variety of avoidable problems.”