Prestige Brand Holdings has voluntarily recalled a batch of its Clear Eyes eye drops after FDA alert

Prestige Brand Holdings has voluntarily recalled a batch of its Clear Eyes eye drops after FDA alert

Nearly 40,000 bottles of eye drops are being pulled from store shelves across the US over concerns about potential contamination, according to the Food and Drug Administration (FDA).

Prestige Brand Holdings, based in Tarrytown, New York, has voluntarily recalled 39,060 bottles of Clear Eyes Maximum Itchy Eye Relief eye drops because of a “lack of assurance of sterility”, an FDA enforcement report states. The FDA classified the action as a Class II recall, defined on the agency’s website as a moderate-risk situation “in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote”.

The recall specifically covers 15ml bottles carrying lot code 2552A and an expiration date of 30 September 2027. The eye drops were distributed by Medtech Products Inc, a Prestige Consumer Healthcare company.

  • Wispy2891@lemmy.world
    6·
    2 days ago

    It happened also before

    https://arstechnica.com/science/2023/04/fda-details-slew-of-failures-at-plant-that-made-eye-drops-linked-to-deaths/

    The facility, it seemed, was primed to produce contaminated products. FDA inspectors noted that Global Pharma didn’t verify that components of the solutions, bought from suppliers, were sterile to begin with. And the areas of the facility where the solution was supposed to be made aseptically—contamination-free—weren’t fit for producing sterile products. That is, the walls, ceilings, and floors were not smooth, hard surfaces that could be readily sterilized as they should be. Instead, there were cracks, protruding nails, and holes in the wall. But, even if the area was cleanable, the company’s protocols for cleaning were also deficient, the report noted.

    FDA inspectors noted problems with cleaning and maintenance of machinery, which could have led to cross-contamination from other products manufactured in the facility. On the second inspection day, an inspector also noted a “black, brown colored greasy deposit” on parts of the filling machine, and the facility’s equipment logbook noted that it hadn’t been cleaned in nearly a month. A few days later, a manager told the inspector that there was “no procedure for cleaning” the filling machine.

    Main reason: in order to make more money they outsourced production from the united states to the cheapest facility that they could find in India

    In this way they saved $0.15 per bottle, who cares if hundreds of people lose vision