The Food and Drug Administration has classified a recall of more than 11 million eye drop cartons as a Class II recall.
The recall affecting 11,960,623 cartons of Rohto Cooling Eye Drops was initiated on July 14 but was classified by the FDA on July 23.
The agency said that the Rohto Cooling Eye Drops may not be sterile, prompting the recall.
The following products are being pulled from store shelves nationwide:
- Rohto Cooling Eye Drops ALL-IN-ONE, 1,033,266 cartons
- Rohto Cooling Eye Drops Max Strength (single, 6,076,306 cartons and twin pack, 499,673 cartons)
- Rohto Cooling Eye Drops Optic Glow, 1,278,457 cartons
- Rohto Cooling Eye Drops Digi Eye, 65,219 cartons
- Rohto Cooling Eye Drops Dry Aid (single, 97,201 cartons and twin pack, 353 cartons)
- Rohto Cooling Eye Drops Cool Relief, 2,910,148 cartons
Click here to see all of the lot numbers and expiration dates.
A press release with instructions on what to do with the recalled eye drops was not released. The FDA, however, did release an enforcement report with the classification, saying that the company, Rohto-Mentholatum, based in Vietnam, initiated the recall.
A Class II recall is "a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote."
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