FDA Warnings and Recall for Eye Care Products Due to Bacterial Contamination

The Food and Drug Administration (FDA) has issued warnings and recalls for several eye care products over the past few months, due to potential contamination with a drug-resistant bacteria, Pseudomonas aeruginosa. The most recent warning was issued for EzriCare Artificial Tears Lubricant Eye Drops, which have been linked to 55 severe eye infections and one death.[0] Global Pharma Healthcare, the company that produces EzriCare and Delsam Pharma artificial tears, has issued a product recall.[1]

Additionally, Apotex Corp. issued a voluntary nationwide recall of Brimonidine Tartrate Ophthalmic Solution and Pharmedica USA LLC issued a voluntary worldwide recall of Purely Soothing 15% MSM Drops, both due to sterility concerns.[2] The FDA encourages consumers to immediately stop using these products and contact a healthcare provider if they experience any signs of infection. These signs may include yellow, green, or clear discharge from the eye, discomfort or pain, redness, blurry vision and increase sensitivity to light.[3]

Individuals who have experienced an adverse reaction or quality issues with the use of any of the recalled products may report it to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.[4] EzriCare Artificial Tears users who have been infected have begun filing lawsuits against Global Pharma Healthcare, Aru Pharma, EzriCare, and others, seeking refunds for the purchase price of the product in class-action lawsuits and compensation for infections and eye problems in individual EzriCare personal injury lawsuits.[4]

0. “FDA recalls 3 brands of eye drops. What patients need to know” UC Davis Health, 14 Mar. 2023, https://health.ucdavis.edu/news/headlines/fda-recalls-3-brands-of-eye-drops-what-patients-need-to-know-/2023/03

1. “Recalled artificial tears eye drops linked to death, blindness and eyeball removals in US” Sky News, 17 Mar. 2023, https://news.sky.com/story/recalled-artificial-tears-eye-drops-linked-to-death-blindness-and-eyeball-removals-in-us-12835953

2. “More OTC Eye Drops Recalled Amid Bacterial Contamination Fears” DrugWatch.com, 14 Mar. 2023, https://www.drugwatch.com/news/2023/03/14/eye-drops-contamination-recall

3. “Blindness and injuries reported after US recalls eyedrops” BBC, 17 Mar. 2023, https://www.bbc.com/news/world-us-canada-64985191

4. “2 More Eye Drops Brands Recalled Over Contamination Risks” Consumernotice.org, 15 Mar. 2023, https://www.consumernotice.org/news/eye-drops-fda-recalls