A recall issued on Wednesday has removed 27 eye drop products from the shelves of major retailers including CVS, Rite Aid, Target and Walmart following a warning from the U.S. Food and Drug Administration (FDA) about three weeks prior, advising against the use of these products.
The recall, initiated by Kilitch Healthcare India, affects products with expiration dates between November 2023 and September 2025. The FDA’s concerns stem from unsanitary conditions discovered at the manufacturing facility, including positive bacterial test results.
Kilitch Healthcare India’s recall is part of a larger pattern of eye drop recalls this year, totaling eight separate announcements involving various brands nationwide. The FDA, in late October, specifically urged consumers to stop using Kilitch’s products due to the risk of eye infections that could lead to partial vision loss or blindness.
As of November 13, Kilitch reported no adverse health effects linked to the recall. However, some of the products may have already been removed from stores earlier this month, following the FDA’s directive to CVS, Rite Aid and Target to withdraw them from shelves and websites.
The recall notice advises distributors and retailers in possession of the recalled products to cease distribution. Consumers are instructed to stop using the recalled eye drops and return them to the purchase location. Bloomberg News revealed that the eye drops were produced in an unsanitary factory in India, where workers reportedly went barefoot and fabricated test results to indicate sterility.
The FDA’s warning led to Cardinal Health recalling six Leader brand eye products in early November and Harvard Drug Group recalling Rugby Laboratories brand eye drops.
Earlier this year, the FDA announced recalls of eye drop products linked to four deaths and multiple cases of vision loss. In August, it cautioned against using two additional eye drop products due to risks of bacterial or fungal contamination.
Separately, the FDA issued a warning to Amazon about distributing seven unapproved products marketed for pink eye treatment. These products, which have been removed from Amazon’s website, include Similasan Pink Eye Relief, The Goodbye Company Pink Eye, Can-C Eye Drops, Optique 1 Eye Drops, OcluMed Eye Drops, TRP Natural Eyes Floaters Relief, and Manzanilla Sophia Chamomile Herbal Eye Drops. The FDA highlighted the increased risk of harm from ophthalmic drug products, as they bypass some of the body’s natural defenses.
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