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Ophthalmic products over-the-counter ophthalmic have been voluntarily recalled due to a manufacturing deviation discovered during an audit of the Food and Drug Administration in the United States, an opinion said.
The Avkare pharmaceutical distributor has been informed of the recall of drugs in consumers by the Recall Society, BRS Analytical Services LLC. The recall has been issued for several products due to manufacturing deviations which “can lead to unacceptable quality products, and it is not possible to exclude the risks of patients resulting from the use of these products”.
The opinion warns consumers to stop using affected products immediately. Avkare said the FDA is aware of the recall and that the danger to health related to the articles is unknown.
USA Today has contacted Avkare for more information.
When were the items distributed?
The recalled products were sent from May 26, 2023 to April 21, 2025, said Avkare.
What products have been voluntarily recalled?
Avkare’s press release includes a detailed graphic with lot numbers and expiration dates of the products recalled below. A reminder notice published on the FDA website has identified the amount of cases involved in the reminder.
- 13,104 cases of solution for lubricating eye drops; National Medicines Code (NDC): 50268-126-15
- 32,876 Case of ophthalmic solution of carboxymethylcellulose sodium; National Medicines Code (NDC): 50268-068-15
- 14,333 Case of ophthalmic solution of polyvinyl alcohol; National Medicines Code (NDC): 50268-678-15
- 1,610 cases of carboxymethylcellulose sodium 1% National Medicines Code (NDC): 50268-066-15
- 13,872 cases of artificial tears ophthalmic solution; National Medicines Code (NDC): 50268-043-15
What should consumers do?
Buyers who may have these products recalled in their inventory are invited to fill out a downloadable PDF form “Quality to return” attached to the recall notice and to fax it to 931-292-6229 or to send it by e-mail to Customerservice@avkare.com.
Then, the company will send the customer a “return to the authorization form” to return the product recalled to the address indicated to obtain a full credit, including shipping costs.
Taylor Ardrey is a press journalist for USA Today. You can reach it at Tarrey@gannett.com.
