Another week translates to another recall to report. The latest update: The FDA has issued a nationwide recall of several Rhoto cooling eye drop products.
The reason: “A lack of assurance of sterility.”
I’m getting some deja vu …
No surprise there, as we recently covered the federal agency’s recalls of +2.5 million bottles of prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, a prescription-based eye drop manufactured by Lupin Limited and distributed across the United States.
Similar to this latest recall: That was also due to a sterility issue.
Noted. Let’s get some more info on this new situation.
On July 14, the FDA first initiated a voluntary recall of specific lots relating to several Rohto eye drop products manufactured by Rohto-Mentholatum Co. Ltd (a Vietnam-based company) and distributed by The Mentholatum Company (see its product page), operating out of Orchard Park, New York.
And the recall classification level?
Fast forward to July 23: This was labelled as a Class II recall, which 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
Now talk products.
Encompassing a grand total of 11,960,623 cartons, these include:
- Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%)
- Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%)
- Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%),
- Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%)
- Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%)
- Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%)
Take note: Two of the products (Max Strength and Dry Aid) are listed twice for two different packaging options (single and twin-pack).
Do we know their respective lot numbers and expiration dates?
Indeed we do. The expiration dates range from July 2026 to February 2029.
As for the specific lot numbers—click here to view.
And where have they been sold?
Aside from directly via the Rohto Eye Drops online shop, Kroger is also listed as an in-person seller.
Contact Rhoto directly for more information on sellers across the country.
Next: Can you tell me more about this “lack of assurance of sterility”?
In product recalls, this generally means a manufacturer is unable to guarantee a product (such as an eye drop) is free from harmful microorganisms, like bacteria or fungi.
Essentially, it 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.
And in this specific recall?
The FDA did not specify what led to the recall. Glance also reached out to Mentholatum; the manufacturer did not immediately respond to our request for comment.
It’s worth mentioning, however: The eye drop brand’s website lists its products as:
- FDA Good Manufacturing Practice (GMP) compliant, stating that all eye drops are “100% sterile, 100% free from contamination, and meet rigorous quality standards”
- International Organization for Standardization (ISO)-13485 certified
- USP Chapter <71> compliant, noting its manufacturing sites are “fully regulated, routinely monitored and tested by the FDA as well as third parties to protect our formulations”
Also noted. Last question: Have there been any related reports of adverse reactions?
Not so far … 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.