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News / Health

Nationwide Recall of Eye Drops and Ophthalmic Products

Several over-the-counter eye products, including artificial tears and lubricant eye drops, have been voluntarily recalled nationwide following an FDA audit that revealed manufacturing deviations. This recall impacts various brands and produ...

Artificial tears, other eye products recalled; consumers urged to discontinue use
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Nationwide Recall of Eye Drops and Ophthalmic Products Image via USA Today

Key Insights

  • **Manufacturing Deviations:** The recall was initiated due to manufacturing deviations discovered during an FDA audit of BRS Analytical Services LLC, the firm contracted by AvKARE.
  • **Potential Health Risks:** While the exact health hazards are unknown, the deviations may lead to products of unacceptable quality, potentially posing risks to patients.
  • **Wide Distribution:** The recalled products were shipped between May 26, 2023, and April 21, 2025, indicating a broad distribution across the nation.
  • **Product Identification:** The recall includes multiple product types, such as Lubricant Eye Drops Solution, Carboxymethylcellulose Sodium Ophthalmic Solution, Polyvinyl Alcohol Ophthalmic Solution, Carboxymethylcellulose Sodium Ophthalmic Gel 1%, and Artificial Tears Ophthalmic Solution.
  • **Consumer Action:** Consumers are advised to immediately discontinue use of the recalled products and follow the return instructions provided by AvKARE to receive a full credit, including shipping costs.

In-Depth Analysis

### Background AvKARE, a pharmaceutical distributor, received notification from BRS Analytical Services LLC regarding manufacturing deviations that could compromise product quality. This led to a voluntary recall of several over-the-counter ophthalmic products. The FDA is aware of the recall, and AvKARE is working to address the situation.

### Specific Products Recalled The recall affects the following products:

  • Artificial Tears Ophthalmic Solution
  • Carboxymethylcellulose Sodium Ophthalmic Gel 1%
  • Carboxymethylcellulose Sodium Ophthalmic Solution
  • Lubricant Eye Drops Solution
  • Polyvinyl Alcohol Ophthalmic Solution

Each product has specific National Drug Codes (NDCs) and lot numbers, which can be found on the FDA's website&ref=yanuki.com and AvKARE's recall notice&ref=yanuki.com.

### How to Prepare 1. **Identify Affected Products:** Check your inventory for the recalled eye drops and ophthalmic solutions. 2. **Discontinue Use:** Immediately stop using any recalled products. 3. **Return Products:** Fill out the "Quality to Return" form available on AvKARE's website&ref=yanuki.com and follow the instructions to return the products for a full refund.

### Who This Affects Most This recall primarily affects individuals who regularly use over-the-counter eye drops for dry eye relief or other ophthalmic purposes. It also impacts retailers and distributors who carry these products in their inventory.

### Data and Trends The FDA's involvement and the detailed recall notices indicate a serious concern for public safety. The number of cases involved, such as the 13,872 cases of Artificial Tears Ophthalmic Solution, highlights the widespread use of these products.

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FAQ

What should I do if I have purchased one of the recalled products?

Immediately discontinue use and follow the instructions on AvKARE's website&ref=yanuki.com to return the product for a full refund.

Are there any known health hazards associated with using the recalled products?

The exact health hazards are unknown, but the manufacturing deviations may lead to products of unacceptable quality, potentially posing risks to patients. It is best to err on the side of caution and discontinue use.

How can I get a refund for the recalled product?

Fill out the "Quality to Return" form on AvKARE's website&ref=yanuki.com, fax it to 931-292-6229, or email it to [email protected]. AvKARE will then send you a Return Authorization Form to ship the product back for a full credit, including shipping costs.

Takeaways

  • Immediately stop using the recalled products.
  • Visit AvKARE's website&ref=yanuki.com to download and complete the return form.
  • Return the product to AvKARE following their instructions to receive a full refund.

Discussion

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Disclaimer

This article was compiled by Yanuki using publicly available data and trending information. The content may summarize or reference third-party sources that have not been independently verified. While we aim to provide timely and accurate insights, the information presented may be incomplete or outdated.

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