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FDA Recalls Two More Brands of Eyedrops After a String of Industry Sterility Issues

Eye drops are a common over-the-counter medication used to treat a variety of eye conditions such as dry eye, allergies, and infections. However, so far this year, there have already been four eye drop recalls by the U.S. Food and Drug Administration (FDA) due to concerns over product safety and quality. Just last week, the FDA added two eye drops to its list over potential sterility issues that could cause serious eye infections, injuries or vision problems. The recalled products are Apotex Corp Brimonidine Tartrate Ophthalmic Solution (0.15%) and Pharmedica USA LLC Purely Soothing 15% MSM Drops.

The Apotex product is used to treat high eye pressure in patients with glaucoma or ocular hypertension. The recall was initiated because some of the bottle caps have developed cracks, which can lead to contamination of the eye drops by bacteria, fungi, or other microorganisms. As of March 8, the Florida-based company stated they have not received reports of adverse events related to the use of their eye drops. The following lots are subject to the recall and were distributed nationwide between April 5, 2022, and February 22, 2023:

  • TJ9848
  • TJ9849
  • TK0258
  • TK5341
  • TK0261
  • TK0262

The Pharmedica product is marketed as a natural remedy for dry eyes, allergies and inflammation. The recall was initiated because the product was found to be non-sterile, meaning it may contain harmful contaminants that could cause eye infections or damage. Pharmedica also claims they have received no reports of illness or injury related to the use of this product to date. Pharmedical recalled two lots of its product: 2203PS01 and 1808051.

These recalls follow recalls just last month on batches of Global Pharma Healthcare’s Artificial Tears Lubricant Eye Drops distributed by EzriCare, LLC and Delsam Pharma  and Artificial Eye Ointment, distributed by Delsam Pharma, in February 2023. Artificial tear products hydrate dry eyes resulting from conditions like aging, allergies, side effects of other medications, or other health conditions. The recalled products are preservative-free and sold over the counter.

In February, the Centers for Disease Control (CDC) announced it had identified 55 patients in 12 states, including Florida, with a rare strain of drug-resistant P. aeruginosa causing permanent vision loss resulting from a corneal infection, hospitalization, and one death due to a systemic infection.

Our lawyers have experience fighting eyedrop manufacturers whose products contain defective components that cause infections. We have seen this before, have litigated and successfully fought these claims and are ready to use our experience to help those injured by this new round of recalls.

If you or someone you love has contracted an eye infection as a consequence of using and of the recalled eyedrops, you may have a case warranting review. If you would like to discuss the facts of your use of this product, contact Cal Warriner, Katie Kiziah, or Victoria Mesa-Estrada at Searcy Denney today at (800) 780-8607.

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Posted By: Samantha Saundry