Recall Notice for Over-the-Counter Eye Products Due to Manufacturing Issues

Recall Notice for Over-the-Counter Eye Products Due to Manufacturing Issues
Grzegorz
Grzegorz27 days ago

A range of over-the-counter eye care products have been voluntarily recalled following the discovery of a manufacturing deviation during a recent audit by the U.S. Food and Drug Administration, according to an official notice.

Pharmaceutical distributor AvKARE was informed about this consumer-level recall by the responsible company, BRS Analytical Services LLC. The recall includes several items due to manufacturing flaws that “could result in products of inadequate quality, and there is potential risk to patients using these products,” the notice indicates.

Consumers are advised to discontinue use of these affected products immediately. AvKARE has confirmed that the FDA is aware of this recall, but the specific health risks associated with the products remain unspecified.

USA TODAY has contacted AvKARE for further information.

When Were the Recalled Products Distributed?

The products in question were distributed between May 26, 2023, and April 21, 2025, as per AvKARE.

Which Products Are Included in the Recall?

AvKARE’s statement provides a comprehensive chart listing the lot numbers and expiry dates of the recalled products. The FDA’s website recall notice details the specific quantity of cases affected:

  • 13,104 cases of Lubricant Eye Drops Solution (NDC: 50268-126-15)
  • 32,876 cases of Carboxymethylcellulose Sodium Ophthalmic Solution (NDC: 50268-068-15)
  • 14,333 cases of Polyvinyl Alcohol Ophthalmic Solution (NDC: 50268-678-15)
  • 1,610 cases of Carboxymethylcellulose Sodium Ophthalmic Gel 1% (NDC: 50268-066-15)
  • 13,872 cases of Artificial Tears Ophthalmic Solution (NDC: 50268-043-15)

What Actions Should Consumers Take?

Customers who have these recalled products are instructed to fill out the “Quality to Return” form available as a PDF from the recall notice. This form should be faxed to 931-292-6229 or emailed to customerservice@avkare.com.

Afterward, the company will issue a “Return to Authorization Form,” enabling the return of the products to the specified address and allowing for a complete reimbursement, including shipping costs.

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