Thousands of eye care products, specifically lubricant eye drops and artificial tears, are being recalled after a “manufacturing deviation” was discovered during a U.S. Food and Drug Administration (FDA) inspection. AvKARE, a pharmaceutical distributor, issued a voluntary recall for five over-the-counter eye care products after being informed by St. Louis-based BRS Analytical Service, LLC.
While the health risks associated with the affected products are currently undetermined, AvKARE expressed that the manufacturing issues might compromise the quality of the products, posing potential risks to users. Consumers holding these products are strongly encouraged to stop using them immediately.
To facilitate the return process, AvKARE is asking customers to complete a recall form on their website, which can then be submitted via fax or email. The company will provide a Return Authorization Form to allow for the safe return of the products and will issue full credit, including any shipping fees incurred during the return.
The list of recalled products includes:
1. **Artificial Tears Ophthalmic Solution**
– NDC: 50268-043-15
– Affected lots and expiration dates span through 2026 and 2027.
2. **Carboxymethylcellulose Sodium Ophthalmic Gel 1%**
– NDC: 50268-066-15
– Affected lots with expiration dates up to 2026.
3. **Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%**
– NDC: 50268-068-15
– Over 32,000 cases reported affected, with expiration dates extending to 2027.
4. **Lubricant Eye Drops Solution**
– NDC: 50268-126-15
– Affected lots include several with expiration dates through early 2027.
It’s pivotal for consumers to stay informed and take appropriate action regarding these recalls to ensure their safety. While recalls can cause inconvenience, they also highlight the enforcement of quality control standards aimed at protecting public health. Taking swift action, such as returning the affected products, is a proactive step towards safety and vigilance in personal health management.