Wisconsin consumers who purchase over-the-counter eye drops to treat dry and itchy eyes should double check their medicine cabinets. Over 75,000 units of Ophthalmic solutions have been voluntarily recalled nationwide due to manufacturing violations, uncertain sterility, and potential risk of contamination.
The recall includes eye lubricants manufactured by BRS Analytical Services that are distributed by AvKARE, a supplier of infection control products and pharmaceuticals. The issue was originally discovered during a FDA audit at BRS Analytical Services and the Enforcement Report indicates deviation of Current Good Manufacturing Practice (cGMP).
Recalled products include:
- Artificial Tears Ophthalmic Solution (Dextran 70.01%, Glycerin 0.2%, Hypromellose 0.3%)
- Carboxymethylcellulose Sodium Ophthalmic Gel 1%
- Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%
- Lubricant Eye Drops Solution (Polyethylene Glycol 400 0.4%, Propylene Glycol 0.3%)
- Polyvinyl Alcohol Ophthalmic Solution 1.4%
For a full list of products, including expiration dates and lot numbers, click here.
In a statement issued by AvKARE, they stated the deviations may lead to quality concerns and that it is not possible to rule out patient risk at this time. AvKARE is urging consumers to stop using these products immediately.
Those with recalled products can complete the recall form and email it to AvKARE who will then provide a Return Authorization (RA) form. If returning the product by mail, consumers should label the return "Ophthalmic Recall.” AvKARE will provide a full credit and shipping costs for any returned eye drop products.
Returns can be sent to:
R&S Northeast LLC
8407 Austin Tracy Road
Fountain Run, KY 42133
