All lots of eye drops that were sold online under two different brands are being recalled after bottles were found to be contaminated with bacteria that could cause infections, leading to blindness and even death.
The recall affects Artificial Tears (carboxymethylcellulose sodium) Lubricant Eye Drops sold by Aru Pharma/Ezricare and Delsam Pharma, which were found to be contaminated with a bacterium called Pseudomonas aeruginosa.
It came after a total of 55 patients reported adverse effects after using eye drops, including the recalled products.
The Centers for Disease Control and Prevention (CDC) said patients presented multiple conditions, including keratitis, endophthalmitis, respiratory infection, urinary tract infection, and sepsis.
Outcomes also included permanent vision loss resulting from cornea infection, hospitalisation, and one death due to systemic (bloodstream) infection, the CDC said.
An advisory alert was issued about possible infections caused by a "rare, extensively drug-resistant strain" of the bacteria Pseudomonas aeruginosa, that the eye drops were found to be contaminated with.
Those impacted were in California, Colorado, Connecticut, Florida, New Jersey, New Mexico, New York, Nevada, Texas, Utah, Washington and Wisconsin.
Global Pharma Healthcare, the manufacturer, issued the recall voluntarily after the CDC's warning.
The over-the-counter product was distributed online across the US, but patients, wholesalers, and retailers are now urged to stop using and distributing the eye drops.
In a recall statement posted on the US Food and Drug Administration website Thursday, Global Pharma Healthcare said: "Use of contaminated artificial tears can result in the risk of eye infections that could result in blindness."
It added: "Global Pharma Healthcare is notifying the distributors of this product, Aru Pharma Inc. and Delsam Pharma and is requesting that wholesalers, retailers and customers who have the recalled product should stop use."
"Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these over-the-counter drug products."
The bacteria strain, which was found to be highly resistant to many antibiotics, was detected in opened bottles of the product, which could mean it was contaminated either during use or during the manufacturing process.
The CDC said unopened bottles of EzriCare Artificial Tears will be tested to determine if the contamination happened during the manufacturing process.
EzriCare, one of the distributors of the impacted eye drops, has set up a website with information for consumers.
The recalled eye drops were packaged in bottles with safety seals and small cartons, with Ezricare drops having the NDC number 79503-0101-15 and UPC number 3 79503 10115 7, and Delsam Pharma drops labelled with the NDC number 72570-121-15 and a UPC number of 72570-0121-15.
Patients experiencing adverse reactions or quality problems with this product may report them to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Download the regular mail form, call 1-800-332-1088 to request and post it or submit it by fax to 1-800-FDA-0178.
