Latest news with #PolyvinylAlcoholOphthalmicSolution
12-05-2025
- Business
Voluntary recall issued for eye drops sold nationwide
Several over-the-counter eye products used to treat dry and irritated eyes have been voluntarily recalled following an audit by the U.S. Food and Drug Administration. AvKARE, a pharmaceutical distributor, issued a voluntary recall notice on its website, noting that the products are being recalled due to "manufacturing deviations" found during the FDA audit. According to the recall notice, the exact health dangers for consumers using the recalled products are unknown, but the company said "deviations may lead to products of unacceptable quality, and it is not possible to rule out patient risks resulting from use of these products." ABC News has reached out to AvKARE for further information. Here is what to know about the products being recalled and what consumers can do. What products are being recalled? Both the FDA and AvKARE have detailed information on their websites about the products being voluntarily recalled. The FDA's website also lists the number of cases involved in the recall: 32,876 cases of Carboxymethylcellulose Sodium Ophthalmic Solution (National Drug Code: 50268-068-15) 13,104 cases of Lubricant Eye Drops Solution (National Drug Code: 50268-126-15) 14,333 cases of Polyvinyl Alcohol Ophthalmic Solution (National Drug Code: 50268-678-15) When were the products distributed? The recalled items were first shipped between May 26, 2023, and April 21, 2025, according to AvKARE. Expiration dates range from April 2025 to March 2027. Click here or here for a full list of expiration dates, lot codes and other product details. What should consumers do? AvKARE is advising consumers to discontinue use of the recalled products immediately. Eye drops sold at stores including CVS, Rite Aid and Target could cause blindness, FDA warns Are consumers able to get a refund? Yes, according to AvKARE. The company is asking consumers to fill out a recall form on its website and fax the completed form to 931-292-6229 or email it to customerservice@ Once the form is received, the company will send consumers a Return Authorization Form to ship the product back to AvKARE. The company says it will issue full credit, including shipping cost, for any returns.
USA Today
12-05-2025
- Business
- USA Today
Artificial tears, other eye products recalled; consumers urged to discontinue use
Artificial tears, other eye products recalled; consumers urged to discontinue use Over-the-counter ophthalmic products were voluntarily recalled due to a manufacturing deviation discovered during a U.S. Food and Drug Administration audit, a notice says. Pharmaceutical distributor AvKARE was notified of the consumer level drug recall by the recalling firm, BRS Analytical Services LLC. The recall was issued for several products as a result of manufacturing deviations that "may lead to products of unacceptable quality, and it is not possible to rule out patient risks resulting from use of these products." The notice warns consumers to stop using the affected products immediately. AvKARE said the FDA is aware of the recall, and the health hazard linked to the items is unknown. USA TODAY reached out to AvKARE for more information. Car recalls: Volvo, Volkswagen, Polestar among over 500,000 vehicles recalled When were the items distributed? The recalled products were shipped from May 26, 2023, to April 21, 2025, AvKARE said. Which products were voluntarily recalled? AvKARE's press release includes a detailed chart with the lot numbers and expiration dates of the recalled products below. A recall notice posted on the FDA's website identified the amount of cases involved in the recall. 13,104 cases of Lubricant Eye Drops Solution; national drug code (NDC): 50268-126-15 32,876 cases of Carboxymethylcellulose Sodium Ophthalmic Solution; national drug code (NDC): 50268-068-15 14,333 cases of Polyvinyl Alcohol Ophthalmic Solution; national drug code (NDC): 50268-678-15 1,610 cases of Carboxymethylcellulose Sodium Ophthalmic Gel 1%; national drug code (NDC): 50268-066-15 13,872 cases of Artificial Tears Ophthalmic Solution; national drug code (NDC): 50268-043-15 What should consumers do? Buyers who may have these recalled products in their inventory are urged to complete a downloadable PDF "Quality to Return" form attached to the recall notice and fax it to 931-292-6229 or email it to customerservice@ Then, the company will send the customer a "Return to Authorization Form" to ship the recalled product back to the listed address to get a full credit, including shipping costs. Taylor Ardrey is a news reporter for USA TODAY. You can reach her at tardrey@
