AUG 25, 2015
Comprehensive Ophthalmology, Refractive Mgmt/Intervention
Allergan is voluntarily recalling certain lots of eye-treatment ointments sold in the U.S. under the Refresh, Lacri-Lube and other brands amid concerns about patient safety.
In a news release Monday, Allergan said the recall is in response to a small number of customer complaints of a black particle, which potentially can be introduced into the product when the cap of the aluminum tube is unscrewed.
The company said complaints include 12 reports of a foreign body in the eye; 2 reports each of eye irritation, product contamination, superficial eye injury and eye pain and 1 report each of eye swelling and blurred vision.
The ointments in question are:
- Refresh Lacri-Lube, 3.5 g and 7 g, for dry eye;
- Refresh P.M., 3.5 g, for dry eye;
- FML (fluorometholone ophthalmic ointment) 0.1%, 3.5 g, an anti-inflammatory agent; and
- Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment) 10%/0.2%, 3.5 g, which combines an antibiotic and a corticosteroid.
The lots subject to the recall have expiration dates that range from April 2017 to March 2018.
Consumers with affected lots of Refresh, Lacri-Lube, Refresh P.M., FML and Belphamide are requested to stop using the products and return them to Allergan. Consumers also are urged to contact their physician or health-care provider about any problems related to use of the recalled products.
To report an adverse event or side effect:
- Download the form or call 800-332-1088 to request the reporting form. Complete and return it to the address on the form, or fax to 800-FDA-0178.