Following a shocking report detailing numerous “unsanitary conditions” at Indian factories, the Food and Drug Administration has ordered 27 products sold at major retailers including CVS, Rite Aid, Target, and Walmart. eye drops were collected.
Kilic Healthcare India Limited has announced that it is selling a number of products with expiration dates ranging from November 2023 to September 2025 after visiting the pharmaceutical giant’s Mumbai factory last month and publishing Ophthalmology products were voluntarily recalled. report Employees at the manufacturing site were said to be working barefoot.
“The deputy production manager confirmed that this is standard practice.”
Additionally, in a room designated for cleaning small machinery parts, “workers were observed removing their hats and combing their hair,” the FDA Department of Health and Human Services report added last month. .
The inspection also looked into the cracked floor, which had not been sealed at the cove joint where the floor meets the wall.
In another example, a sterile bottle fell onto a non-sterile conveyor belt and the report said the bottle was “allowed to remain on the filling line even though it tipped over where the top of the bottle made contact with the conveyor.” The book says:
An operator was also seen wiping down the conveyor belt while leaning over unfilled sterile bottles. “The bottles were then allowed to remain on the line and the filling and capping operations could take place.”
The recall was announced Wednesday, about a month after an FDA Department of Health and Human Services inspection found that Kilic’s “sterile drug manufacturing facility” in Mumbai, India, was not entirely sterile.
F.D.A. I have posted the complete list It identified the recalled products and lot numbers and directed consumers of the recalled eye drops to return the products to their place of purchase and to report any side effects to FDA’s MedWatch Adverse Event Reporting Program.
Since then, CVS and Rite Aid have removed their respective store brands Lubricant Eye Drops and Multi-Action Relief Drops from their shelves, among other ophthalmic products, while Target has removed their High Performance Lubricant Eye Drops. Walmart had to be wary of Equato Hydration PF. Lubricant eye drops.
Other infectious eye products are sold under the Rugby, Leader and Velocity brands.
The Post has reached out to Kilic for comment.
CVS said that after receiving the recall notice from the FDA, it “immediately ceased sales of all products in stores and online.”
“We are committed to ensuring that the products we offer are safe, work as intended, and satisfy our customers, and we are fully cooperating with the FDA in this matter,” a spokesperson for the retailer said. told the Post.
“We take the quality and safety standards of all of our suppliers seriously and work with manufacturers,” a Walmart spokesperson said. We have removed this product from stores and blocked its sale at cash registers. Purchasers of the product are advised to discontinue use. ”
Cardinal Health, which manufactures products under the Leader brand name, press release The company warned patients of the “potential risk of eye infection that can cause partial vision loss or blindness” and said it was “arranging the return of all recalled products.” .
Representatives for Rite Aid, Target, Rugby and Velocity have not yet responded to The Post’s requests for comment.
The recall comes about two weeks after the FDA warned consumers against 26 other products that treat dry eye and inflammation, saying they can cause eye infections and lead to vision loss.
The FDA warning came after investigators found “unsanitary conditions” at the manufacturer’s facilities, but federal officials did not name the manufacturer.
Environmental sampling of critical drug production areas at the facility also yielded positive bacterial test results, the FDA said.
However, CVS and Cardinal Health pointed out that the product in question was supplied by Velocity Pharma.
