Eye Drop Recall due to Serious Contamination leading to Infections and Vision Loss
Health Alert from Hopewell Lambertville Eye
Before you start to treat yourself for an "eye condition" it is more appropriate to seek the advise of your eye doctor at Hopewell Lambertville Eye. It is not advisable to self treat fore what you think could be "dry eye" "allergy" "red eye" could be an indication of more serious and advanced eye problems. When self treating with OTC (over the counter drops) you could be causing more serious damage and potential for vision loss as seen in recent FDA warnings and recalls.
FDA eye drop recall: Don’t use these Amazon, CVS, Rite Aid, Walmart and Target brands. FDA warns consumers not to purchase or use certain eye drops from several major brands due to risk of eye infection. Dozens of products are associated with a risk of eye infections that could result in partial vision loss or blindness. More notably, on October 27, 2023, the FDA warned consumers about 26 over-the-counter eye drops with potential sterility issues that can cause eye infections, leading to partial or total vision loss. The list of drops has been recently updated and published 11-16-2023.
(see list below)
Recent History of Recalled Eye Drops
Amazon, CVS health, Target, Rite Aid, Leader, Rugy and Velocity Pharma all have been warned to remove multiple recalled eye drops.
In a letter addressed to Andrew Jassy, President and CEO of Amazon, the US Food and Drug Administration (FDA) issued a warning to the company regarding the sale of unapproved ophthalmic drugs. Recently, the FDA urged customers to avoid a slew of eyedrops due to the possible risk of eye infections that could result in vision loss or blindness. This is just one of many times the FDA has issued a warning on unapproved ophthalmic products in 2023.
The letter specifies 7 drugs that Amazon is “responsible for introducing or delivering for introduction into interstate commerce” which are “unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”), 21 U.S.C. 355(a).” Furthermore, the letter states that the introduction of these products into interstate commerce is “prohibited under sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).”
On Nov. 15, 2023, the FDA announced Kilitch Healthcare India Limited is voluntarily recalling 27 eye drop products sold in the U.S. due to a risk of infection. Kilitch Healthcare India Limited has voluntarily recalled 25 over-the-counter eye drop products after the FDA warned of unsanitary conditions and potential safety concerns, according to a company press release. Kilitch Healthcare India Limited has voluntarily recalled 25 eye drop products due to potential safety concerns.
Eye drops are more vulnerable to contamination than other over-the-counter products, because “ophthalmologic" products need to be sterile, which is not true of oral and dermatological products. Over-the-counter eye drops have a different regulatory process than prescription products. “All the eye drops in this current recall are over-the-counter products. Prescription eye drop products should not be affected,”
You should not be afraid of using eye drops. All of the recalled eye drops should be off the shelves by now. Eye drops are sterile and safe to use. In particular, continue using your prescription eye drops as your doctor prescribed them, if in doubt, about the safety of drops or the condition of concern it is better to ask your or visit with the doctors at Hopewell Lambertville Eye
The recalled products with retailer name, which include those with expiration dates ranging from November 2023 to September 2025, are:
[11/15/2023] The manufacturer, Kilitch Healthcare India Limited, has issued a voluntary recall for these products. FDA recommends confirming the products on the list the agency provided.
[11/3/2023] Cardinal Health Inc. has initiated a voluntarily recall for all lots of six Leader brand ophthalmic products. The list FDA provided on October 27 included five products branded as Leader. The list has been updated to include the sixth product.
Additionally, Harvard Drug Group LLC also initiated a voluntary nationwide recall for all lots of two Rugby Laboratories brand eye drops.
The agency has updated the list of products to include the national drug codes (NDCs) that have been confirmed. FDA will provide additional information as it becomes available.
[10/30/2023] FDA is updating the list of over-the-counter eye drop products consumers should not purchase or use to include Equate Hydration PF Lubricant Eye Drop 10 mL sold by Walmart in stores and online. Walmart is removing the product from their store shelves and website.
[10/27/2023] FDA is warning consumers not to purchase and to immediately stop using 26 over-the-counter eye drop products due to the potential risk of eye infections that could result in partial vision loss or blindness. Patients who have signs or symptoms of an eye infection after using these products should talk to their health care provider or seek medical care immediately. These products are marketed under the following brands:
- CVS Health
- Leader (Cardinal Health)
- Rugby (Cardinal Health)
- Rite Aid
- Target Up & Up
- Velocity Pharma
These products are intended to be sterile. Ophthalmic drug products pose a potential heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses.
FDA recommended the manufacturer of these products recall all lots on October 25, 2023, after agency investigators found insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility. FDA also recommends consumers properly discard these products.
CVS, Rite Aid and Target are removing the products from their store shelves and websites. Products branded as Leader, Rugby and Velocity may still be available to purchase in stores and online and should not be purchased.
FDA has not received any adverse event reports of eye infection associated with these products at this time. FDA encourages health care professionals and patients to report adverse events or quality problems with any medicine to FDA’s MedWatch Adverse Event Reporting program:
https://eyewire.news/news/fda-warns-consumers-not-to-purchase-or-use-26-brands-of-eye-drops?c4src=article:infinite-scroll
https://www.cbsnews.com/news/eye-drops-recall-full-list-2023/
https://www.dailymail.co.uk/health/article-12461307/MORE-brands-eyedrops-recalled-FDA-fears-contain-deadly-germs-customers-fall-ill-eye-infections.html
https://www.ophthalmologytimes.com/view/fda-issues-warning-letter-to-amazon-for-selling-unapproved-eye-care-products?utm_source=sfmc&utm_medium=email&utm_campaign=11222023_OT_OYS-23-OPD0522_GLA-24-OPD0542_eNL_Oyster%20Point%20Dry%20Eye%20TRC_Glaucoma&eKey=aG9wZXdlbGxleWVAa2VubmV0aGRhbmllbHMubmV0
