‘Life-Threatening Infection’: FDA Recalls Eye Drops Over Bacterial, Fungi Contamination

The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times

The U.S. Food and Drug Administration (FDA) has issued a recall of eye drop products manufactured by Dr. Berne’s Whole Health Products due to worries about contamination.

The voluntary recall is applicable to “all lots” of Dr. Berne’s MSM DROPS 5%, 15% Solution, Dr. Berne’s Organic Castor Oil Eye Drops, and Dr. Berne’s MSM MIST 15% Solution, according to an Aug. 26 FDA recall notice.

An analysis by the agency had found a lot of MSM DROPS 5% Solution failed “sterility with both bacterial and fungal contamination found in the product.”

The recalled products are used as lubricating eye drops and were distributed via Dr. Berne’s online store.

“Using contaminated eye drops could result in minor to serious vision-threatening infection which could possibly progress to a life-threatening infection. To date, Dr. Berne’s has received 2 reports of adverse events related to this recall,” the notice said.

The company is notifying all distributors and customers by email and arranging for the return of the recalled products. Those who have bought the products have been asked to stop using them and return the items to Sun Star Organics, 988 Main Street, Orange, CA 92867.

The recall notice includes images of the products being withdrawn.

The recall comes a few days after the FDA issued a warning asking consumers not to buy and to “immediately stop” using two eye drop products—Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops.

The products contain methylsulfonylmethane (MSM) as an active ingredient. The items are “unapproved drugs and illegally marketed” in the United States, the agency said. “There are no legally marketed ophthalmic drugs that contain MSM as an active ingredient,”

Testing of the products revealed that they were “contaminated with microbes and were not sterile,” it stated.

Dr. Berne’s eye drops recall is the latest in a series of similar recalls done by other manufacturers in the industry.

On Feb. 2, Global Pharma Healthcare recalled all lots of their Artificial Tears Lubricant Eye Drops due to potential contamination. The product was being distributed by EzriCare LLC and Delsam Pharma.

The U.S. Centers for Disease Control and Prevention (CDC) had alerted the FDA about an investigation into a multi-state outbreak of Pseudomonas aeruginosa bacteria possibly linked to the product.

On March 1, Apotex Corp. recalled six lots of its Brimonidine Tartrate Ophthalmic Solution, 0.15% eye drops. Some of the unit caps of the bottles had cracked, thus posing a risk of contamination. A few days later on March 3, Pharmedica USA LLC recalled two lots of Purely Soothing, 15% MSM Drops due to “non-sterility.”

CDC Investigation

In May, the CDC reported about the outbreak of “an extensively drug-resistant strain of Pseudomonas aeruginosa.” The strain had never before been reported in the United States prior to this outbreak, the agency stated. By May 15, the CDC had identified 81 patients in 18 American states.

“Patients reported over 10 different brands of artificial tears, and some patients used multiple brands. EzriCare Artificial Tears, a preservative-free, over-the-counter product packaged in multidose bottles, was the brand most commonly reported. This was the only common artificial tears product identified across the four healthcare facility clusters.”

The CDC warned that the drug-resistant bacteria was capable of spreading among people who have not used eye drops.

“The bacteria can spread when one patient carrying the bacteria exposes another patient, or when patients touch common items or when healthcare workers transmit the germs which is why infection control, like hand hygiene, is so important,” the agency told CNN.

The CDC asked patients who have used EzriCare or Delsam Pharma’s Artificial Tears and see signs or symptoms of eye infection to immediately seek medical care.

Some of the symptoms include yellow, green, or clear discharge from the eye; redness of the eye; blurry vision; a foreign body sensation in the eye; and increased sensitivity to light.

The CDC advised healthcare facilities to discontinue the use of these products and instruct patients using them to do the same.

Buying Eye Drops

Eye drops are an important part of eye care for Americans. According to data from Statista, 117.45 million U.S. citizens used eye drops and eye wash in 2020.

Eye drops are used for various purposes, including relieving dryness or redness in the eye, soothing itchiness and other irritation caused due to reactions to allergens, and treating infections among others.

Experts advise people not to treat eye drops as a DIY project and to consult a doctor about which ones to buy and how to use them safely.

“People don’t always pay attention to what they’re buying or why they’re buying it,” Dr. Ronald Benner, an optometrist at Southern Montana Optometric Center, said to CNET.

“And, while there were some serious consequences to those drops [involved in the recent scare], they really weren’t getting good, quality vision care—they were just buying over-the-counter drops. We strongly recommend that all patients consult with their local optometrist to make sure that they’re using the right drop for the right reasons,” he said.

Eye drops can interact with other drugs a patient may be taking. As such, it is important to consult with a doctor whether a specific eye drop can be taken. Any allergies must also be revealed to the doctor.