Another month, another recall to report on.
This time around: The FDA has issued a nationwide recall for over 39,000 bottles of CLEAR EYES Maximum Itchy Eye Relief eye drops due to a “lack of assurance of sterility.”
And this follows those two prior recalls we just heard about, right?
Indeed. The two other recalls in the news:
- Over 2.5 million bottles of Lupin Limited’s prednisoLONE Acetate Ophthalmic Suspension, USP, 1%
- Nearly 12 million Rohto cooling eye drop products
Though, take note: This latest recall was actually issued at the end of July (July 29, to be exact).
Noted. So what do we know about it?
The ongoing voluntary recall was issued by Prestige Consumer Healthcare (formerly known as Prestige Brands, Inc.), an independent provider of over-the-counter (OTC) healthcare products based in Tarrytown, New York.
Its relation to this product: Prestige is the parent company of Medtech Products, Inc., its subsidiary that operates as a manufacturer / distributor of several OTC brands—including CLEAR EYES.
And the product in question?
CLEAR EYES is an OTC eye drop brand for relieving minor eye redness, dryness, and irritation.
- Check out the four drops in its product portfolio.
As for the product included in this recall: CLEAR EYES Maximum Itchy Eye Relief is intended to be used to relieve itchy eyes, dryness, burning, redness, and other irritations.
So regarding this situation—has the FDA added a recall classification level yet?
Indeed it has. The federal agency updated the classification on Aug. 14 to a Class II recall.
This level is reserved for instances where the “use of or exposure to a violative product” could potentially cause:
- Temporary or medically irreversible adverse health consequences
- A remote probability of serious adverse health consequences
And exactly how many of these drops are affected?
While there are a total of 39,060 15 mL bottles included in this recall, it’s limited to just one specific lot consumers need to be aware of:
- Lot number: 2552A
- Expiration date: 09/30/2027
And where have they been sold?
According to the CLEAR EYES product website, the drops are sold online and in stores at:
- Kroger
- Drug Mart
- Giant Eagle
- Meijer
To note: As of Aug. 17, the product listing was removed from all websites except Drug Mart.
So what does a “lack of assurance of sterility” actually mean?
This generally translates to a manufacturer being unable to guarantee that a product is free from harmful microorganisms, such as bacteria or fungi.
And more importantly: It also indicates a failure in the manufacturing, testing, or processing of a product that could allow for its potential of contamination—and, as a result, the risk of infection to consumers.
Got it. And any insights as to what led to this specific recall?
Aside from its Class II classification, the FDA didn’t provide any further details.
Glance also reached out to Prestige for comment; as of the time of this article’s publication, the manufacturer did not respond.
Have there been any related reports of adverse reactions?
Not as far as we know. To note: We also asked Prestige that question.
However, if any consumers or eyecare providers do have adverse events to report, they should submit a form online via the FDA’s MedWatch Adverse Event Reporting program or by mail/fax.