More than 3.1 million bottles of eye drops sold at several major retailers are being recalled due to concerns about sterility, according to a notice from the Food and Drug Administration.
Why were the eye drops recalled?
K.C. Pharmaceuticals, Inc., based in Pomona, California, voluntarily recalled several eye drop products due to “lack of assurance of sterility” in the products. Sterility refers to the likelihood that no living microorganisms remain on a product after sterilization,” according to a March 3 FDA notice and STERIS.
The products were sold at Walgreens, CVS, H-E-B, Kroger, and Publix under brand names, including Sterile Eye Drops (multiple varieties), Eye Drops Advanced Relief, Dry Eye Relief Eye Drops, and Artificial Tears Sterile Lubricant Eye Drops.
The FDA classified the affected items as a Class II recall, which, according to the federal agency, is “a 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.”
Details on the affected eye drop products
Here’s everything consumers need to know about the eye drop products, including brand names, how many recalled bottles, the ingredients and where they were sold.
Sterile Eye Drops AC
This recall includes 182,424 affected bottles of Sterile Eye Drops AC, distributed under multiple private-label brands, including Best Choice, Walgreens, Good Sense, Equaline, TopCare, Meijer, CareOne, and H-E-B. The product contains tetrahydrozoline HCl 0.05% and zinc sulfate 0.25% and was sold in 0.5 fl. oz. (15 mL) bottles across major retailers nationwide.
Eye Drops Advanced Relief
This recall includes 303,216 affected bottles of Advanced Relief eye drops distributed under brands including Walgreens, CVS Health, Kroger, GoodSense, DG Health, Foster & Thrive, and others. The formulation includes dextran 70 0.1%, polyethylene glycol 400 1%, and tetrahydrozoline HCl 0.05% in 15 mL sterile bottles sold nationwide.
Dry Eye Relief Eye Drops
A total of 1,023,096 bottles of Dry Eye Relief Eye Drops are included in this recall, with distribution across brands such as Rite Aid, H-E-B, Meijer, TopCare, Good Neighbor Pharmacy, Foster & Thrive, and DG Health. The lubricant formula contains 0.2% glycerin, 0.2% hypromellose, and 1% polyethylene glycol 400.
Ultra Lubricating Eye Drops
This recall includes 245,184 affected bottles of Ultra Lubricating Eye Drops sold under brands including Walgreens, CVS Health, Kroger, Meijer, Foster & Thrive, and QC Quality Choice. The sterile lubricant formula contains 0.4% polyethylene glycol 400 and 0.3% propylene glycol.
Sterile Eye Drops Original Formula
The recall includes 378,144 affected bottles of Original Formula Sterile Eye Drops distributed under the Walgreens, Kroger, H-E-B, Rite Aid, DG Health, Good Neighbor Pharmacy, and other private-label brands. The active ingredient is tetrahydrozoline HCl 0.05%, and products were sold in 15 mL bottles nationwide.
Sterile Eye Drops Redness Lubricant
This recall includes 315,144 affected bottles of redness relief lubricant eye drops sold under Walgreens, Rite Aid, Good Neighbor Pharmacy, Equaline, Foster & Thrive, and similar store brands. The formula contains 0.25% glycerin and 0.012% naphazoline HCl.
Sterile Eye Drops Soothing Tears
This recall includes 74,016 affected bottles of Soothing Tears eye drops, distributed by Rugby Laboratories and Walgreens. The sterile lubricant formulation contains 0.4% polyethylene glycol 400 and 0.3% propylene glycol.
Artificial Tears Sterile Lubricant Eye Drops
This recall includes 589,848 affected bottles of private-label artificial tear products distributed by companies including Leader, CVS Health, Kroger, TopCare, and Good Neighbor Pharmacy. The lubricant formula contains 0.5% polyvinyl alcohol and 0.6% povidone. The total number of bottles was not fully detailed in the write-up.
The recall was initiated on March 3 and classified on March 31. Consumers can find out more information about the products, including lot codes and UPC codes, in the FDA’s enforcement report, according to WGN9.
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