Thousands of over-the-counter eye care products, including lubricating eye drops and artificial tears, have been voluntarily recalled following a manufacturing deviation discovered during a U.S. Food and Drug Administration audit. The pharmaceutical distributor AvKARE was alerted to the recall by BRS Analytical Services LLC and promptly issued a notice cautioning consumers. The recall was initiated due to manufacturing deviations that could result in products of unacceptable quality, leading to potential risks for patients using the affected products.
Although the specific health hazards associated with using the recalled products remain unknown, AvKARE emphasized the importance of immediate cessation of their use. To facilitate the recall process, consumers are advised to access a downloadable "Quality to Return" form available on AvKARE's website. This form, once completed, should be faxed to 931-292-6229 or emailed for further instructions on returning the products. AvKARE has assured customers that they will receive a full credit, inclusive of shipping costs, upon returning the recalled items.
The recalled eye care products were distributed between May 26, 2023, and April 21, 2025, with detailed information on the affected lots and expiration dates provided by AvKARE. Notably, these products were shipped in numerous cases, each containing 24 cartons. It is crucial for consumers to cross-check the National Drug Code cNDCc numbers and expiration dates of the products purchased during the specified period to determine if they are part of the recall.
AvKARE's comprehensive recall notice underscores the extent of the recall and highlights the urgency for affected consumers to take immediate action. The company's proactive approach in providing clear instructions for the recall process aims to ensure customer safety and mitigate any potential health risks associated with the use of the affected products.
For any additional inquiries or information regarding the recall, concerned individuals are encouraged to directly reach out to AvKARE. The recall serves as a reminder of the importance of stringent quality control measures in the manufacturing and distribution of healthcare products to safeguard consumer health and well-being.
As the story unfolds, more insights and updates may emerge regarding the impact of the recall and any further actions taken by regulatory authorities. Stay tuned for the latest developments on this evolving recall affecting over-the-counter ophthalmic products and the measures being undertaken to address the situation.
