What should I do if I have purchased one of the recalled eye drops?
Immediately discontinue use and fill out the recall form on AvKARE's website to receive a full refund.
Yanuki
ARTICLE DETAIL
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Health / Recalls
Nationwide Recall of Eye Drops Due to Manufacturing Concerns
Several over-the-counter eye products, including artificial tears and lubricating eye drops, are being voluntarily recalled nationwide. The recall, initiated by BRS Analytical Services LLC, follows an audit by the U.S. Food and Drug Adminis...
Key Insights
- **Manufacturing Deviations:** The recall is due to manufacturing deviations found during an FDA audit, which may lead to products of unacceptable quality.
- **Unknown Health Risks:** The exact health dangers to consumers are currently unknown, but the company has not ruled out potential patient risks.
- **Affected Products:** The recall includes multiple ophthalmic solutions and gels, including Artificial Tears, Carboxymethylcellulose Sodium Ophthalmic Solution and Gel, Lubricant Eye Drops, and Polyvinyl Alcohol Ophthalmic Solution.
- **Distribution Dates:** Recalled products were shipped between May 26, 2023, and April 21, 2025.
In-Depth Analysis
The voluntary recall was prompted by an FDA audit that uncovered manufacturing deviations in several over-the-counter eye care products. These deviations raise concerns about the quality and safety of the products, potentially exposing users to unknown health risks.
The recalled products include:
- 13,872 cases of Artificial Tears Ophthalmic Solution (NDC: 50268-043-15)
- 1,610 cases of Carboxymethylcellulose Sodium Ophthalmic Gel 1% (NDC: 50268-066-15)
- 32,876 cases of Carboxymethylcellulose Sodium Ophthalmic Solution (NDC: 50268-068-15)
- 13,104 cases of Lubricant Eye Drops Solution (NDC: 50268-126-15)
- 14,333 cases of Polyvinyl Alcohol Ophthalmic Solution (NDC: 50268-678-15)
AvKARE advises consumers to check their inventory and immediately stop using any recalled products. Consumers can fill out a recall form on AvKARE's website and return the products for a full refund, including shipping costs. Retailers are also urged to remove the products from their shelves.
**How to Prepare:**
1. Check your eye drop inventory for the recalled products. 2. Discontinue use of any recalled products immediately. 3. Fill out the recall form on AvKARE's website. 4. Return the products to AvKARE for a full refund.
**Who This Affects Most:**
This recall primarily affects individuals who use over-the-counter eye drops to treat dry and irritated eyes. These products are commonly used by people with allergies, contact lens wearers, and those experiencing age-related dry eye.
FAQ
Are there any known health risks associated with using the recalled products?
The exact health risks are unknown, but the company advises against using the products due to potential manufacturing deviations.
Takeaways
- Several over-the-counter eye drops have been recalled due to manufacturing deviations.
- Consumers should immediately discontinue use of the recalled products.
- AvKARE is offering full refunds, including shipping costs, for returned products.
- Check product codes and lot numbers to determine if your eye drops are affected.
Discussion
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Disclaimer
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