Tarrytown healthcare products distributor Prestige Brands International Inc. is demanding nearly $1.9 million from the manufacturer of Clear Eyes for costs incurred in recalling the eye drops.
Prestige accused Altaire Pharmaceuticals Inc. of violating a duty to deliver safe products, in a July 14 complaint filed in Westchester Supreme Court.
Altaire, of Aquebogue, Suffolk County, makes over-the-counter eye drops that it sells under several brand names.
Prestige, a $2.9 billion consumer products company by market capitalization, promotes Clear Eyes on its website as the product “your eyes deserve” for “up to 12 hours of soothing comfort.”
It supplies Clear Eyes to retailers such as Amazon, CVS, Target, Walgreens and Walmart.
In July 2019, Altaire issued urgent notices to Prestige to recall Clear Eyes Redness Relief, Maximum Itchy Eye Relief and Maximum Redness Relief. Recall notices also went to the Accu-Wash, FreshKote and Grandall labels.
Altaire cited “lack of sterility assurance,” according to a company announcement posted by the U.S. Food and Drug Administration. It had not received any reports of adverse reactions but the announcement stated that use of a “non-sterile product … may result in serious and potentially life-threatening infections or death.”
In March 2020, eight months after the recall, the FDA sent Altaire CEO Assad S. Sawaya a warning letter, based on an inspection of the manufacturing facility three months before the recall.
The letter identified violations of good manufacturing practices. For instance, inspectors had found equipment on a filling line that could not be maintained or readily cleaned because the line was rigged with aluminum foil and masking tape to prevent bottle tops from falling into a hopper.
Lab technicians had falsified data for testing microbial contamination. Workers were seen wearing inappropriate clothing for protecting products from contamination. Scientifically sound specifications had not been used to assure that drugs conformed to appropriate standards of strength, quality and purity.
The FDA made similar observations in 2013, 2015, and 2017, the warning letter stated, and the repeated failures “demonstrate that executive management oversight and control over the manufacturing of drugs is inadequate.”
Altaire asked Prestige and three other wholesalers to recall the eye drops from their retailers.
Prestige says that process — removing Clear Eyes from store shelves, destroying supplies, and other steps — cost $1,878,313.
It accuses Altaire of breach of contract for delivering a product with quality control concerns, and of warranty breaches for delivering products that were not merchantable, of high quality, or fit for their intended purpose. It is also demanding, under terms of the purchase orders, that Altaire pay its legal fees.
An Altaire representative who would not identify herself said the company does not comment on pending litigation.
Prestige is represented by Manhattan attorneys Robert A. Stern and Richard T. Freilich.
