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By Benjamin Lynch
US Politics and National Affairs Reporter
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U.S. consumers have been warned not to use several eye ointments, after the products were recalled by a pharmaceutical company over concerns they could cause infections.
Brassica Pharma Pvt. Ltd. issued a recall on the U.S. Food and Drug Administration (FDA) website on February 26 following a company announcement on February 22. It was "due to lack of sterility assurance" in the products after problems were discovered during an inspection.
"For those patients who use these products, there is a potential risk of eye infections or related harm," Brassica said. "These products are intended to be sterile. Ophthalmic drug products pose a potential heightened risk of harm to users because drugs applied to the eyes bypass some of the body's natural defenses."
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The list of affected products is as follows:
- Equate Lubricant Eye Ointment (Mineral Oil 42.5%, White Petrolatum 57.3%, Lanolin Alcohols) – universal product code (UPC) 681131395298
- Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%, Microcrystalline Wax, Stearic Acid, Wheat Germ Oil) – UPC code 681131395304
- CVS Health Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%, Microcrystalline Wax, Stearic Acid Wheat Germ Oil – UPC code 050428634141
- Lubricant PM Ointment – UPC code 371406124356
You can see a full list of the products, universal product code, lot numbers, national drug code numbers, package descriptions, pictures of the products and use by dates here.
Consumers have been advised to speak to their doctor or healthcare provider if they have experienced problems with any of the products, which were distributed "nationwide" to retailers. Brassica said that no reports of "adverse events" before February 16 had been reported.
It's unclear why the products weren't sterile before release. Newsweek has approached the company for further comment via email.
Recalls in the drug industry aren't uncommon, and they are issued when a product may be harmful to a person in some way.
According to the FDA website, there have been a total of nine company recalls by pharmaceutical companies since the beginning of the year. This includes separate products to treat male erectile dysfunction, athlete's foot and cough syrups.
One recall issued by Leiters Health in January warned of the potential for a "superpotent" drug used in IV bags.
The products, which were "vancomycin IV bags, phenylephrine IV bags, and fentanyl IV" were distributed to hospitals across the U.S.
The "bags are being recalled due to the potential for superpotency because they may contain twice the labeled amount of drug," the January 5 recall, announced on the FDA website on January 8, said.
The issue occurred when it was discovered the "semi-automated IV bag filling equipment used to fill the recalled batches" would not eject the IV bags when compressed air tanks ran low or when a leak was detected. Leiters Health said this caused the "recalled IV bags to be dosed twice."
Newsweek contacted Leiters Health for an update via email. The company previously said it hadn't received any reports of adverse events linked to the recall.
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