Massive Dry Eye Medication Recall Causes Shortages

medication recall, dry eye

One after another, eye drop manufacturers have announced a medication recall for drops used to treat dry eye.  It started with a recall of generic brands and quickly spread to the name brands.  At this point, experts are calling on manufacturers who have NOT recalled their eye drops to speak up and make themselves known to the public because dry eye sufferers are having trouble finding the medication they need.

Products Included in Dry Eye Medication Recall

The dry eye medication recall includes more than 14 brands.  These include generic brands sold by Wal-Mart, Walgreens, and CVS.  Name brands affected include OCuSOFT, Perrigo, Accutome, and Prestige/Clear Eyes.

The uniting thread in the recall is the manufacturer.  Altaire Pharmaceuticals manufactures all of the products in this recall.  The manufacturer began the recalls due to concerns over the “potential for non-sterility.” Altaire insists, however, that none of the tested products has actually failed a sterility test.

Regardless, recalls of this magnitude speak to the potential danger to consumers.  Companies do not go through the time and expense of massive recalls unless there are serious concerns about the product.

The First Sign of a Massive Medication Recall

In early July, Wal-Mart stores started sending notices to customers who may have purchased eye drops named in the medication recall.  Already, the U.S.  Food and Drug Administration (FDA) had posted notice of quite a few recalled products, Wal-Mart’s Equate brand was included in that list.  Initially, the recall included about 10 name brands.  As more brands and products join the list, the current total is now closer to 120 individual products.

Why Are the Eye Drops Being Recalled?

Altaire has been vague and somewhat cagey in their announcement of the recall.  Their statement published through the FDA says they are recalling the products because of “management concerns” about insufficient quality assurance measures in their manufacturing facilities.

The FDA concurred with the potential danger to consumers, agreeing that the issues Altaire management brought to the agency’s attention do, in fact, indicate “a lack of sterility assurance.” The agency says that non-sterility in an item that is intended to be sterile can have serious, even deadly, consequences for the user.  Essentially, the potential for contamination is there, but the company says none of the samples they tested showed any contamination.

They announced, with the caps lock on, that no adverse event reports are on record with their company or with the FDA.  They further exclaimed that none of their internal tests and third-party tests showed any results that were out of specification limits for the product.

Out of an abundance of caution, the manufacturer is removing massive numbers of their products from the marketplace, further exacerbating the already existing shortage on retail eye-care products.

Eye Ointment Causes a Domino Effect

Patients who struggle with dry eye battle a condition so painful that some sufferers are driven to suicide.  Many of the over-the-counter ointments that patients rely on have been in very short supply for a year and a half.  One ointment that has been consistently out of stock is Allergan’s Refresh P.M., which has only recently made a return to store shelves.

“[The] recalls, which also include dozens of ointments, could not possibly be coming at a worse time”

said Rebecca Petris, founder of the not-for-profit Dry Eye Foundation.

This medication recall and the subsequent shortages are serious matters because of the excruciating pain dry eye suffers endure.  The Dry Eye Foundation recently began a project with the aim of documenting the experiences of dry eye sufferers in their community.  Petris said dry eye is a condition that sounds “trivial” and “insignificant,” but is anything but.   Her foundation is taking an extensive survey of what people experience in order to raise awareness for the condition.

She said some people experience dry eye as a simple nuisance, but for some people the condition causes major distress.  People who suffer severe dry eye experience:

  • Burning, stinging pain
  • Light sensitivity
  • Interference in work and personal life

It is easy to see why this medication recall is a big problem for those who struggle with dry eye.  Without a consensus from the medical community about the best way to treat the condition, the majority of sufferers are completely dependent on over-the-counter products for relief.

Dry Eye Sufferers Find Relief Difficult

Many people who struggle with dry eye have had the frustrating experience of an eye doctor telling them their eyes look healthy, or that their medical exam doesn’t indicate their symptoms are severe.  Yet, these are the same people who are buying out restorative eye ointment at every opportunity.

This is something the Dry Eye Foundation seeks to change.  They have developed a survey that should facilitate more meaningful conversations between patients and eye doctors. Hopefully, this will result in more people receiving the treatment they need sooner.

In the mean time, over-the-counter eye drops and ointments are the only recourse for many of the people who live with dry eye.  Now, they are not getting the help they need because of this massive dry eye medication recall.

What Consumers Should Do about a Medication Recall

For consumers, a massive recall like this one is certainly concerning.  Consumers who battle a painful condition like dry eye may find it difficult to get relief.  The best thing that consumers can do is talk to their doctor or pharmacist about alternative treatments.  Find out what treatment options are available, and advocate for answers.

Consumers who suffer an injury due to a medication or medical device recall should contact an attorney to find out more about their legal rights.  Consumers have the right to trust that the products sold to them are safe.  When that trust fails, the manufacturer should be accountable.

To learn more about this or another medication recall, contact Drug and Device Watch.  Our team of legal professionals can help you understand and protect your legal rights as a consumer.  Call us at 1-888-458-6825 or contact us online via our contact form.