Recall Thousands Eye Products: A recent audit by the U.S. Food and Drug Administration (FDA) has led to the voluntary recall of nearly 76,000 cases of eye care products by BRS Analytical Service, LLC. The recall affects several of the company’s eye drop products, including artificial tears and lubricating eye solutions.
Reason for the Recall
The recall was initiated due to “manufacturing CGMP deviations,” which indicates that the products may not meet FDA quality standards. Although no specific health issues have been reported, the company is recalling the products as a precautionary measure to ensure consumer safety.
Affected Products
The recall includes the following products:
1. Artificial Tears Ophthalmic Solution: 13,872 cases recalled (Drug Code: 50268-043-15)
2. Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%:
– 1,610 cases recalled (Drug Code: 50268-066-15)
– 32,876 cases recalled (Drug Code: 50268-068-15)
3. Lubricant Eye Drops Solution (Polyethylene Glycol 400 / Propylene Glycol): 13,104 cases recalled (Drug Code: 50268-126-15)
4. Polyvinyl Alcohol Ophthalmic Solution 1.4%: 14,333 cases recalled (Drug Code: 50268-678-15)
Still on Recall Thousands Eye Products
Product Details
The affected products were first shipped between May 26, 2023, and April 21, 2025, and have expiration dates ranging from April 2025 to March 2027. This means that some of these products may still be in use by consumers.
Consumer Action
If you have one of the recalled products, stop using it immediately. To obtain a refund, consumers can fill out a recall form and send it to AvKARE by fax or email. After submitting the form, you will receive instructions on how to return the product and get a full refund, including shipping.
Recent FDA Actions
This recall is not an isolated incident. In recent years, the FDA has taken several actions related to eye care products, including:
– October 2023: The FDA warned consumers about 26 over-the-counter eye care products due to potential risks of eye infections.
– September 2023: The FDA issued warning letters to eight companies for illegally marketing unapproved eye products.
– Earlier wave of recalls in 2023: The FDA recalled certain eye drops, including EzriCare Artificial Tears, due to contamination risks and reported cases of infections, hospitalizations, vision loss, and death.
Conclusion
The recall of these eye care products highlights the importance of ensuring the quality and safety of products used for eye care. Consumers should be aware of the products affected and take necessary steps to protect their eye health.
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