July 29, 2014 — Bausch & Lomb is recalling Muro 128, an over-the-counter eye ointment, because it may be contaminated with sharp crystals that can cause eye irritation or a corneal abrasion.
Muro 128 is used for nighttime relief of corneal edema. Patients apply a small amount to the inside of the eyelid every 3 to 4 hours or as directed by a doctor.
The Class II recall was announced by the U.S. Food and Drug Administration (FDA) on July 2. It affects about 850,000 products with expiration dates between June 2014 and October 2016. Wholesalers and retailers were notified on May 30, when Bausch & Lomb warned:
“Bausch & Lomb chose to initiate this recall based on data which showed crystal precipitate formation in the tube. An increase in the number of complaints related to crystal formation has prompted Bausch & Lomb to recall the product in the interest of public safety.”
It is possible that the product could cause injury to the cornea leading to foreign body sensations in the eye, irritation, or corneal abrasions. The Wall Street Journal reports that one woman said it felt like she had “shard of glass” in her eyes. Another customer complained that the recall was not publicized well enough.
Bausch & Lomb said the crystals may have formed when the products were improperly exposed to freezing temperatures during the winter. The tubes carry a “do not freeze” warning label.
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