Medicines

Eye Drop Recalls (Updated List 2023)

Eye drops are a type of medication or solution that is specifically formulated for application into the eyes. They are typically used to treat various eye conditions and provide relief from symptoms such as dryness, redness, itching, and irritation. Eye drops can be either prescription or over-the-counter (OTC) products, depending on the specific medication and its intended use.

There are different types of eye drops available, each designed to address specific eye conditions or symptoms. Here are some common types:

1.        Lubricating Eye Drops: Also known as artificial tears, these are used to relieve dryness and discomfort caused by insufficient tear production or environmental factors such as wind or dry air.

2.        Allergy Eye Drops: These are formulated to alleviate symptoms associated with allergic reactions affecting the eyes, such as itching, redness, and watering.

3.        Redness-Relief Eye Drops: Also known as “get-the-red-out” drops, these are designed to temporarily reduce eye redness caused by minor irritation, eye strain, or fatigue. They work by constricting the blood vessels in the eyes.

4.        Anti-Inflammatory Eye Drops: These prescription eye drops contain medications that help reduce inflammation in the eyes, commonly used for conditions such as conjunctivitis (pink eye), uveitis, or ocular allergies.

5.        Antihistamine Eye Drops: These eye drops contain antihistamines to relieve itching and discomfort caused by allergic reactions affecting the eyes.

6.        Antibiotic Eye Drops: These are prescribed to treat bacterial eye infections, such as conjunctivitis or corneal ulcers.

7.        Glaucoma Eye Drops: These prescription eye drops are used to lower intraocular pressure in the eyes, helping to manage and prevent damage to the optic nerve caused by glaucoma.

Eye drops play a crucial role in maintaining and promoting eye health. They provide targeted relief and treatment for a wide range of conditions, including dryness, redness, itching, allergies, inflammation, and infections. By delivering medications, lubricants, or soothing agents directly to the eyes, eye drops help alleviate discomfort, reduce inflammation, and prevent further damage or complications. They can also help stabilize tear film, enhance moisture, and improve overall eye hydration, which is essential for optimal vision and comfort. Whether through lubricating dry eyes, controlling allergic reactions, managing inflammation, or treating infections, eye drops provide a convenient and effective way to support eye health, alleviate symptoms, and promote clearer, more comfortable vision.

However, eye drops and artificial tears may be recalled for many reasons. These can include quality control issues, such as the presence of impurities, contamination, or deviations from the required manufacturing standards. Recalls can also occur if there are labeling errors, misleading information, or inadequate instructions for use, which could pose risks to consumers. Additionally, safety concerns, such as adverse reactions or reports of harmful side effects associated with a particular product, may prompt a recall. The aim of recalls is to ensure consumer safety and prevent further use of potentially compromised or unsafe eye drops or artificial tears. Manufacturers, regulatory agencies, and healthcare professionals closely monitor products to identify any issues and take appropriate actions to protect public health. In this article, we shall be taking an in-depth look at the recent recalls of eye drops and artificial tears in the pharmaceutical industry.

Which eye drops are recalled 2023?

Several drug companies and U.S. Food and Drug Administration (FDA) have initiated several eye drop recalls due to safety and manufacturing issues they include:

EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears: In January 2023, the CDC and FDA warned against using EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears due to links with drug-resistant Pseudomonas aeruginosa bacteria strain. Four deaths, vision loss in 14 individuals, and four eyeball removals were reported. In February Global Pharma recalled EzriCare and Delsam Pharma’s eye drops. In the same month, a woman in Florida sued Global Pharma after an eye drop infection led to her eye being surgically removed. FDA warns against using Global Pharma’s eye ointment due to possible contamination.

Apotex Brimonidine Tartrate Ophthalmic Solution: In March 2023 Apotex recalled Brimonidine Tartrate Ophthalmic Solution 0.15% prescription eye drops due to cracked bottle caps affecting sterility.

Purely Soothing 15% MSM Drops: In March 2023, Pharmedica recalls Purely Soothing 15% MSM Drops due to lack of sterility. These drops are used for treating eye irritation and swelling.

Other Notable Eye Drop Recalls in the Pharmaceutical Industry include:

1.        Altaire Pharmaceuticals Inc.: In recent years, Altaire Pharmaceuticals has issued multiple recalls for various eye drop products due to concerns related to quality control issues and potential contamination. These recalls have included products manufactured for several well-known retailers and private-label brands.

2.        Johnson & Johnson: In 2019, Johnson & Johnson initiated a voluntary recall of certain lots of its OTC lubricant eye drops due to concerns over the potential presence of small glass particles in the product. The recall was conducted as a precautionary measure to ensure consumer safety.

3.        Bausch + Lomb: In 2019, Bausch + Lomb voluntarily recalled specific lots of its Muro 128 ophthalmic solution due to concerns over potential microbial contamination. The recall was initiated as a precautionary measure to ensure consumer safety.

4.        Novartis: In 2018, Novartis Pharmaceuticals Corporation announced a voluntary recall of select lots of its over-the-counter eye drop products, including brands such as Similasan, due to concerns over microbial contamination. The recall was initiated after routine testing detected the presence of mold in specific lots.

5.        Perrigo Company: In 2018, Perrigo Company plc initiated a voluntary recall of its over-the-counter lubricant eye drops due to concerns over potential non-sterility. The recall was conducted in response to customer complaints and subsequent investigations.

6.        Alcon: In 2017, Alcon, a division of Novartis, issued a voluntary recall of specific lots of its over-the-counter eye drops due to concerns over a lack of assurance of sterility. The recall was initiated after an internal quality review identified potential issues with the manufacturing process.

7.        Akorn Inc.: In 2017, Akorn Inc. announced a voluntary recall of several ophthalmic products, including eye drops, due to concerns over microbial contamination. The recall was initiated after routine testing detected the presence of microorganisms in certain lots of the products.

4.        Allergan: In 2013, Allergan voluntarily recalled specific lots of its over-the-counter Refresh Plus lubricant eye drops due to concerns over potential microbial contamination. The recall was initiated after routine testing detected the presence of a specific type of bacteria in some lots of the product.

It’s important to note that recalls are part of the regulatory process and are taken as a precautionary measure to ensure consumer safety. To obtain the most current and accurate information, we recommend checking official sources such as the websites of regulatory agencies like the U.S. Food and Drug Administration (FDA) or contacting the manufacturers directly for any recent eye drop recalls in the pharmaceutical industry. These sources will provide you with the most up-to-date information regarding any recalls or safety alerts associated with specific eye drop products.         

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Dr. Oche Otorkpa PG Cert, MPH, PhD

Dr. Oche is a seasoned Public Health specialist who holds a post graduate certificate in Pharmacology and Therapeutics, an MPH, and a PhD both from Texila American University. He is a member of the International Society of Substance Use Professionals and a Fellow of the Royal Society for Public Health in the UK. He authored two books: "The Unseen Terrorist," published by AuthorHouse UK, and "The Night Before I Killed Addiction."
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