Eye Drops Recalled Due to Contamination Risk

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Several types of AvKare brand eyedrops have been recalled due to contamination concerns linked to manufacturing violations, which may pose a risk to users, the company announced.

Although no illnesses have been reported, the Food and Drug Administration (FDA) classified the recall as Class II, meaning the products could cause temporary or medically reversible health problems. While the exact risk to users is unclear, concerns about product quality prompted the recall.

Products affected

The recall covers a range of eye lubricants manufactured by BRS Analytical Services and distributed by AvKARE, a health care company that supplies pharmaceuticals and infection control products. The affected items 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%

Consumers are urged to stop using these products immediately. A full list of products, expiration dates and product codes may be found here.

Advice for consumers

Anyone who has the recalled eyedrops should complete the recall form and send it to customerservice@avkare.com or fax it to 931-292-6229—whether or not you are returning any product. AvKARE will then provide a Return Authorization (RA) form. If returning the product, include a copy of the recall notice in the package and clearly label the shipping box “Ophthalmic RECALL.”

R&S Northeast LLC​
8407 Austin Tracy Rd​
Fountain Run, KY 42133

AvKARE will provide a full credit, including shipping costs, for any returned items.