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Eyedrop Recall 2023 and Infections Were Result of Lack of FDA Regulation

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Apr 14, 2024

Eyedrop Recall 2023 and Infections Were Result of Lack of FDA Regulation

How a drugstore staple, made in an Indian factory and tainted with an antibiotic-resistant superbug, slipped past the FDA. Pseudomonas aeruginosa is a rod-shaped bacterium a fraction of a millimeter

How a drugstore staple, made in an Indian factory and tainted with an antibiotic-resistant superbug, slipped past the FDA.

Pseudomonas aeruginosa is a rod-shaped bacterium a fraction of a millimeter long. In a petri dish, it smells of corn tortillas. It’s opportunistic, invading any tissue that’s already compromised, and can be lethal: Among the especially vulnerable, the mortality rate can be as high as 50%. But perhaps the bacterium’s most notable characteristic is how hard it is to kill. The hardiest of pseudomonas are antibiotic-resistant superbugs that rage on no matter what drugs doctors throw at them.

In May 2022, an unusually virulent strain appeared for the first time in the US, in a hospital patient in Los Angeles. Over the summer three more local cases emerged. As doctors tried to fight the bug, the Centers for Disease Control and Prevention began to track it, reviewing every location and item the patients had in common. Pseudomonas aeruginosa can spread even among people who never came into contact with the original source. The bacteria showed up in Connecticut, then Utah. It was found in people’s lungs and in their blood. It took eight months for the agency to determine the culprit: over-the-counter eyedrops. The two affected brands were widely available for less than half the price of better-known ones. They weren’t counterfeit. They weren’t imported illegally. They were made in India and sold by two US distributors in boxes stamped with the drug inventory numbers that the Food and Drug Administration issued.