Eye Drop Recall Impacts 67,000 Bottles Nationwide

Eye Drop Recall Impacts 67,000 Bottles Nationwide

Eye Drop Recall Impacts 67,000 Bottles Nationwide

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More Than 67,000 Bottles of Eye Drops Have Been Recalled Nationwide

Eye Drops Recall: What You Need to Know

As the winter season approaches, many people struggle with dry, itchy eyes due to harsh weather conditions. Eye drops are a common solution to relieve discomfort and irritation, but recent developments have shed light on a nationwide recall affecting over 67,000 bottles of a popular eye drop product. Here's what you need to know:

The Recall Details

The U.S. Food and Drug Administration (FDA) issued an updated recall notice on November 17 for Klarity-C Cyclosporine 0.1% preservative-free ophthalmic drops manufactured by Imprimis NJOF, LLC. The recall, which includes 67,091 bottles, was initiated due to concerns over the potency of certain batches of the product.

According to the FDA, the affected eye drops were found to be sub-potent, meaning they may not contain the full therapeutic strength necessary for effective treatment. While the likelihood of severe health consequences is low (classified as a Class III event), the sub-potency of the medication can still impact its overall effectiveness.

Identifying the Affected Products

If you have purchased Klarity-C Cyclosporine 0.1% preservative-free ophthalmic drops for "office use," be sure to check the product's label for the National Drug Code (NDC) 71384-514-05. Additionally, the affected bottles will bear one of the following lot codes and expiration dates:

  • Lot 25JAN029 - Exp. Date: Nov. 07, 2025
  • Lot 25JAN042 - Exp. Date: Nov. 14, 2025
  • Lot 25JAN054 - Exp. Date: Nov. 21, 2025
  • Lot 25MAR021 - Exp. Date: Dec. 07, 2025
  • Lot 25APR017 - Exp. Date: Jan. 04, 2026

Understanding Cyclosporine and Its Uses

Cyclosporine is an immunosuppressant medication commonly prescribed for managing chronic eye-surface inflammation, increasing tear production, and alleviating symptoms like dryness, redness, and irritation. It is also effective in treating conditions such as vernal keratoconjunctivitis, an allergic eye disorder.

According to the Mayo Clinic, Cyclosporine ophthalmic preparations can be formulated as a solution or an emulsion to be applied directly to the eye. The affected drops fall under the category of "Sterile Ophthalmic Emulsion," meaning they contain unmixable liquids that may not be fully dissolved.

Stay Informed About Health Recalls

It is essential to stay updated on product recalls, especially when they involve medications or medical devices. If you believe you have purchased or used the recalled eye drops, contact your healthcare provider for further guidance. Patient safety is paramount, and being proactive in monitoring recalls ensures your well-being.

Conclusion

With over 67,000 bottles of eye drops recalled nationwide, it is crucial to verify your product's batch number and expiration date to prevent any potential health risks. By staying informed and attentive to product recalls, you can protect yourself and your loved ones from using sub-potent medications. Remember, your health and well-being should always be a top priority.

Remember to prioritize your health and safety when using medical products.

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