Several eye care products manufactured by AvKARE, located in Pulaski, Tennessee, have been voluntarily recalled after an FDA audit identified manufacturing deviations from current Good Manufacturing Practices (cGMP). The recall, initiated by BRS Analytical Service, LLC, affects consumers nationwide but includes products distributed in Tennessee. The potential health hazard to users is currently unknown, but the deviations may result in products of unacceptable quality, posing possible risks to patients.
The recalled products, distributed between May 26, 2023, and April 21, 2025, include:
* NDC# 50268-043-15 Artificial Tears Ophthalmic Solution
* NDC# 50268-066-15 Carboxymethylcellulose Sodium Ophthalmic Gel 1%
* NDC# 50268-068-15 Carboxymethylcellulose Sodium Ophthalmic Solution
* NDC# 50268-126-15 Lubricant Eye Drops Solution
* NDC# 50268-678-15 Polyvinyl Alcohol Ophthalmic Solution
Consumers and healthcare providers are urged to immediately discontinue use and remove these products from inventory.
All customers must complete the “Quantity to Return” section and customer information block, even if no affected product is on hand. Forms should be faxed to 931-292-6229 or emailed to [email protected]. A PDF version of the recall notice is available for download and submission.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
For more information, visit here.
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