There have been a wave of eye drop recalls this year, with the U.S. Food and Drug Administration (FDA)
There have been a
wave of eye drop recalls this year, with the U.S. Food and Drug Administration
(FDA) recently announcing a nationwide voluntary recall of another 27 products.
On Oct. 27, the
agency released a list of 26 products that consumers should not purchase and
should stop using due to "the potential risk of eye infections that could
result in partial vision loss or blindness."
A few days later,
the FDA added one more product to the list.
The products are
marketed under the following brands, the agency stated in its announcement:
CVS Health
Leader (Cardinal
Health)
Rugby (Cardinal
Health)
Rite Aid
Target Up & Up
Velocity Pharma
"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," the FDA
noted.
The agency called
for the manufacturers to recall all lots of the specified products due to
"unsanitary conditions in the manufacturing facility and positive
bacterial test results from environmental sampling of critical drug production
areas in the facility."
CVS, Rite Aid and
Target all said they would remove the products from their store shelves and
websites, the FDA stated.
"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," the
FDA said in its announcement.
Thus far, there
have been no reports of adverse events related to the October recall.
Earlier in the
year, however, the January 2023 recall of EzriCare or Delsam Pharma’s
Artificial Tears resulted in 81 people reporting infections across 18 states,
Benner noted.
The FDA can only
make recommendations and does not have the authority to issue mandatory recalls
— that is left up to the individual retailers and manufacturers.
What consumers
should do
Using contaminated
artificial tears increases the risk of eye infections that could result in
blindness or death, Benner warned.
"Patients who
have used these products and/or have signs or symptoms of an eye infection
should seek medical care immediately," he said.
"Some eye
infections can lead to further complications, especially if left
untreated."
Signs of a
potential eye infection symptoms may include the following, he said.
Redness of the eye
or eyelid
Eye pain or
irritation
Watery eyes
Feeling of
something in your eye (foreign body sensation)
Increased
sensitivity to light
Blurry vision
Even if someone
has not experienced any of these symptoms but has used one of the recalled
products, Benner said that person should see their optometrist for a
comprehensive exam to assess the front surface of their eye.
"If you have
used [one of the] products or have experienced any new and/or prolonged
irritation in your eyes, visit AOA.org to book an appointment with an AOA
doctor of optometry near you," he recommended.
Anyone who owns
the recalled eye drops should follow the FDA’s guidelines for throwing the
products away, which may involve taking them to a drug take-back site, Benner
noted.
The FDA also
encourages health care professionals and patients to report adverse events or
quality problems with any medicine to FDA’s MedWatch Adverse Event Reporting
program.
Before consumers
treat themselves with over-the-counter (OTC) eye drops, the AOA recommends
consulting with their local optometrist and also checking the FDA’s website for
an up-to-date list of products being recalled.
"When talking
with your optometrist, it’s important to share any prescribed and
over-the-counter medications currently in use and ask for their professional
opinion," Benner told Fox News Digital. "This can also help ensure
that an appropriate treatment plan is in place."
CVS Health
provided the following statement to Fox News Digital regarding the product
recalls: "Upon receiving notification by the FDA, we immediately stopped
the sale in-store and online of all products supplied by Velocity Pharma within
the CVS Health Brand Eye Products portfolio."
"Customers
who purchased these products can return them to CVS Pharmacy for a full refund.
We’re committed to ensuring the products we offer are safe, work as intended
and satisfy customers, and are fully cooperating with the FDA on this
matter."
COMMENTS