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
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    3 hours 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

  • m-p{3}@lemmy.ca
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    18 hours ago

    That’s what happens when you let RFK Jr rub the top of the bottle under his armpits before packaging.

  • TrackinDaKraken@lemmy.world
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    24 hours ago

    And, the hits just keep on coming!

    Why? Because that money needed to go to the filthy rich, because they didn’t have it yet. Product and food safety be damned, they all have access to healthcare, they’ll be fine.

    33%

    • jacksilver@lemmy.world
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      4 hours ago

      I was actually curious about this. Based on historic data we aren’t seeing an increase in recalls (yet). It’s possible each recall is worse (affecting more products or people), but I didn’t see enough information to analyze that. I suspect that we’re really just seeing more news articles because of the really bad lettuce recall.

    • Seleni@lemmy.world
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      20 hours ago

      But—but… the Libertarians told me that a free, deregulated market was the bestest thing ever! They’d never lie to me!

      Seriously, though, anyone who unironically says free markets are a good thing is an idiot, an ass, or both.

    • PriorityMotif@lemmy.world
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      20 hours ago

      The current government has set the tone and workers and managers are cutting corners because it’s “liberal bullshit”. There’s no reason for this stuff to happen other than incompetence .

      • Bakkoda@lemmy.world
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        22 hours ago

        It’s a voluntary recall. They took it upon themselves to publicly recall a product. Why would they bribe anyone?

  • switcheroo@lemmy.world
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    18 hours ago

    I want a fucking adult in charge! Wtf??? How do these grifting pieces of shit sleep at night? God damn, if blue takes over again these ratfucks need jail time!

  • Buffalox@lemmy.world
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    23 hours ago

    The bottles were all sterile, and that is considered extremely unhealthy by the secretary of health who ordered them recalled immediately. Eye drops are from now on required to be based on raw water, so we all can have pretty eyes like Robert F. Kennedy Jr.

  • treadful@lemmy.zip
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    22 hours ago

    I can’t seem to find a reference, but didn’t DOGE actually close the office that was specifically tasked with preventing eyedrops from blinding people?

    • Manjushri@piefed.social
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      3 hours ago

      Yep. You’re 100% correct. I did a search and came up with this.

      If you’ve ever used eye drops that didn’t blind you, thank Dr. Timothy J. Pohlhaus. As of yesterday, he’s gone.

      And if you’ve ever been injected with a sterile drug that helped heal you instead of killing you, you have relied on the services of the Food and Drug Administration’s Office of Manufacturing Quality, where Pohlhaus worked for 15 years and was a senior policy adviser.

      Pohlhaus was one of the FDA’s few leading experts on sterile manufacturing for drugs. “I work to ensure that when people get a purportedly sterile drug product, that it is actually sterile”—as in, free of any contaminant, toxic or otherwise—Pohlhaus told VF.

      He helped write the policies that guided manufacturers, worked to close loopholes that threatened safety, and trained the FDA’s investigators to uncover sterility failures at manufacturing plants scattered across the globe.

      And he was among the thousands of employees at the FDA and other federal health agencies who were abruptly informed on the morning of April 1 that their services were no longer needed.