Valent Pharmaceuticals, Bausch & Lomb unit has recalled about 850,000 tubes of an eye-care ointment because some tubes contained tiny crystal particles that could injure the cornea.
Bausch & Lomb said Friday it believed the crystal particles formed when the tubes of Muro 128 ointment were exposed to freezing temperatures during shipments last winter.
The problem could cause injury to the cornea, leading to eye irritation and abrasions, Bausch & Lomb said in a recall notice it sent to retailers and distributors May 30, which instructed them to return the product. The recall wasn't widely publicized; the U.S. Food and Drug Administration posted some details of the recall on its website this week.
The over-the-counter ointment is typically used as a nighttime treatment for corneal edema, or swelling of the outermost layer of the eye. Users are supposed to apply a small amount to the inside of the eyelid every three to four hours or as directed by a doctor.
Bausch & Lomb said it initiated the voluntary recall in the interest of patient safety after an increase in the number of complaints it received from users about a "gritty, sandlike feeling" in the eye after use of the product.
The recall affects tubes of Muro 128 distributed in the U.S., Canada and Hong Kong but not in other regions, said a Bausch & Lomb spokeswoman.
The company investigated and didn't find any problems with its manufacturing process, the spokeswoman said. Instead, Bausch & Lomb blamed the "extreme weather conditions" of winter, saying the affected products may have been exposed to freezing temperatures after leaving company-owned facilities. Freezing temperatures can cause the crystal formations in the salt-based product, the spokeswoman said; boxes containing the tubes carry a "do not freeze" label.
One woman said it felt like "shards of glass" were in her eyes after using the product. Another complained that Bausch & Lomb didn't sufficiently alert consumers to the recall.
Bausch & Lomb said the recall notice was only sent to wholesalers, retailers and eye-care providers, not to consumers, after discussions with the FDA.
The FDA assigned a "Class II" status to the recall, which the agency reserves for products that could cause temporary or reversible problems, or where the risk of serious health problems is remote.
The recalled lots contained expiration dates ranging from June 2014 to October 2016.
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