The U.S. Food and Drug Administration (FDA) has issued a nationwide recall of more than 76,000 eye care products due to potential safety concerns. The recall affects various ophthalmic solutions distributed by AvKARE, a Tennessee-based healthcare company.
According to the FDA, the recall was initiated after an audit revealed significant violations of Current Good Manufacturing Practice (CGMP) at the manufacturing facility. These deviations may result in products of unacceptable quality, posing risks to patient safety.
*Recalled Products:*
The recall includes five ophthalmic solutions:
1. Artificial Tears Ophthalmic Solution
2. Carboxymethylcellulose Sodium Ophthalmic Gel 1%
3. Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%
4. Lubricant Eye Drops Solution
5. Polyvinyl Alcohol Ophthalmic Solution 1.4%
*Consumer Action:*
Consumers are advised to:
– Stop using the recalled products immediately
– Return the products to AvKARE for a full credit, including shipping costs
– Complete the recall form and send it to [email protected] or fax it to 931-292-6229
*Risk Level:*
The FDA has classified the recall as Class II, indicating a situation where use of or exposure to the product may cause temporary or medically reversible adverse health consequences.
The FDA continues to monitor the situation and urges consumers to prioritize their eye health and safety. If you have any concerns or questions, consult with your healthcare provider or contact AvKARE directly.
