A nationwide recall has been issued for a number of eye care products in the U.S. as officials urged people to stop using them “immediately.”
The voluntary recall involving BRS Analytical Services, LLC – based in St. Louis – was announced by the Food & Drug Administration late last month and classified last week.
Healthcare distributor AvKARE said it was notified of the recall “to the consumer level,” saying it was “due to manufacturing cGMP deviations identified during an audit by the FDA.”
It’s not clear what risks are associated with the potential “deviations,” but AvKARE said they could lead to products with “unacceptable quality, and it is not possible to rule out patient risks resulting from use of these products.”
The FDA classified the recall as a Class II, which is defined as “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.”
The recalled products include:
#Product DescriptionRecall NumberClassificationCode InformationProduct QuantityReason for Recall1Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromellose 0.3% (Eye Lubricants) Lubricant Eye Drops, STERILE, 0.5 FL OZ (15 mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-043-15.D-0404-2025Class IILot, expiry: Lot 126, exp 10/26/25; Lot 127, exp 10/30/25; more…13,872 cases (24 cartons per case)cGMP deviations and lack of assurance of sterility.2Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodium 1% Eye Lubricant, Lubricant Eye Gel, Soothing Gel, Sterile, 0.5 FL OZ (15mL) per bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-066-15.D-0405-2025Class IILot, expiry: Lot 114, exp 9/04/25; Lot 115, exp 9/06/25; Lot 116, exp 9/10/25; Lot 207, exp 12/05/261,610 cases (24 cartons per case)cGMP deviations and lack of assurance of sterility.3Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Carboxymethlycellulose Sodium 0.5% Eye Lubricant, Lubricating Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-068-15.D-0406-2025Class IILot, expiry: Lot 103, exp 4/26/25; Lot 104, exp 5/03/25; more…32,876 cases (24 cartons per case)cGMP deviations and lack of assurance of sterility.4Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Propylene Glycol 0.3% Eye Lubricant, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-126-15.D-0407-2025Class IILot, expiry: Lot 117, exp 9/20/25; Lot 118, exp 9/25/25; more…13,104 cases (24 cartons per case)cGMP deviations and lack of assurance of sterility.5Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-678-15.D-0408-2025Class IILot, expiry: Lot 120, exp 10/02/25; Lot 122, exp 10/09/25; more…14,333 cases (24 cartons per case)cGMP deviations and lack of assurance of sterility.According to AvKARE, the items were distributed and shipped between May 26,023, and April 21, 2025.
The company urged suppliers to “examine your inventory to determine if you have any of the lots” impacted by the recall.
“If so, immediately discontinue use and remove it from active inventory,” the company said in a notice on its website, adding that it will “issue full credit including shipping costs for any returns.”
“We regret any inconvenience that this may cause,” they said.
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