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.

  • Manjushri@piefed.socialEnglish
    3·
    15 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.