Over 75,000 cases of eye care pharmaceutical  products recalled,

May 14, 2025 - 09:57
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Over 75,000 cases of eye care pharmaceutical  products recalled,

Over 75,000 cases of eye care pharmaceutical  products recalled, FDA enforcement report says

The pharmaceutical testing lab BRS Analytical Service recalled products used to relieve dry and irritated eyes after "deviations" were found in adhering to FDA safety regulations.
Female putting eye drops in her eye.
More than 75,000 cases of eye drops have been recalled due to "deviations" from FDA regulations to ensure their safety.

More than 75,000 cases of eye drops have been voluntarily recalled by a pharmaceutical testing lab after an audit by the Food & Drug Administration identified "deviations" from Current Good Manufacturing Practices standards meant to keep products safe and effective.

The products, which are used to relieve dry and irritated eyes, have been voluntarily recalled by BRS Analytical Service, a pharmaceutical testing laboratory, after the audit by the FDA, according to AvKare, a manufacturer of pharmaceutical products.

Here's what to know.

What eye drops are being recalled?

The recall involves the following products, according to the notice issued by AvKare. The products were shipped between May 26, 2023, and April 21, 2025.

Anyone who purchased these products should stop using them immediately.

  • NDC# 50268-043-15 Artificial Tears Ophthalmic Solution
  • NDC# 50268-066-15 Carboxymethylcellulose Sodium Ophthalmic Gel 1%
  • NDC# 50268-068-15 Carboxymethylcellulose Sodium Ophthalmic Solution
  • NDC# 50268-126-15 Lubricant Eye Drops Solution
  • NDC# 50268-678-15 Polyvinyl Alcohol Ophthalmic Solution

Reason behind recalling?

The audit by the FDA found "deviations" from Current Good Manufacturing Practice (cGMP),{Good Manufacturing Practice (GMP) refers to a set of standards that help ensure products are made consistently and meet quality requirements. It's especially important in industries like pharmaceuticals, food, and medical devices, where safety and effectiveness are critical. GMP covers everything from the handling of raw materials and cleanliness of equipment to staff training and production processes. By following these guidelines, companies can avoid contamination, mistakes, and defective products. Regulatory bodies like the FDA and WHO oversee GMP compliance through regular checks and certifications. Sticking to GMP not only protects consumers but also helps businesses maintain their reputation and meet legal and quality expectations. Overall, it plays a key role in producing safe, reliable products.
 according to the FDA.}

The regular audit by the FDA also found a "lack of assurance of sterility" for the products, according to the FDA notice.

AvKare's release added that the health hazard to anyone using the drops is "unknown," but that deviations in cGMP "may lead to products of unacceptable quality" and that it's "not possible to rule out patient risks."

What should you do if you have any of the recalled products?

In addition to discontinuing any use of the products, AvKare is requesting consumers to complete a recall form and either fax to 931-292-6229 or email it to customerservice@avkare.com.

After filling out the form, AvKare will send a Return Authorization Form to return any recalled products for full credit and any shipping costs

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