Bausch + Lomb blames weather for recall of 880,000 tubes of eye ointment

The polar vortex that caused low temperatures in towns and cities across the eastern U.S. is now long gone, but its effects are still being felt. Having closed schools, roads and businesses over the winter, the cold weather has now been blamed by Bausch + Lomb for a recall of 880,000 tubes of eye ointment.

Bausch + Lomb began recalling 850,000 tubes of Muro 128 ointment--plus 35,000 tubes of an unbranded sodium chloride product sold by Major Pharmaceuticals--after users complained of a "gritty, sandlike feeling" in the eye, The Wall Street Journal reports. The Valeant Pharmaceuticals ($VRX)-owned ophthalmic specialist was unable to find the source of the problem at the manufacturing plant, leading it to conclude that the extreme cold experienced over the winter may have caused crystals to form in the product during shipping.

Muro 128 is shipped in boxes warning distributors to keep the products from freezing, but with temperatures plunging to as low as -37°F in Minnesota, this appears to have been too great a task for the logistics team. The recall extends to products sold in the U.S., Canada and Hong Kong. Bausch + Lomb sent recall notices to wholesalers, retailers and eye-care providers--but not to consumers--in each affected area after discussions with FDA. Bausch + Lomb sent the letter on May 30. Information posted more recently by FDA lists April 10 as the recall initiation date.

The handling of the recall drew criticism from some users of Muro 128, who took to Bausch + Lomb's Facebook page to complain that the lack of notification about the recall meant they continued to use the ointment despite it irritating their eyes. People have also been struggling to get hold of Muro 128, with the product in short supply. Bausch + Lomb said it shipped new stock to distributors in mid-June.

- read the WSJ article (sub. req.)
- here's the recall notice (PDF)
- and FDA page