Allergan Recalls Contaminated Eye Ointments
Aug. 26, 2015 — Allergan is voluntarily recalling certain lots of various eye ointments, because some users reported them to be contaminated, the pharmaceutical company announced.
A small number of customers found a small black particle attached to the product’s cap, the company said Monday in a news release posted on the FDA web site. Unscrewing the cap from the aluminum tube can create the particle. Users run the risk of the particle getting into the ointment.
Problems reported by customers include foreign bodies in the eye, superficial eye injury, pain, swelling, and blurred vision.
Two of the recalled ointments, the Refresh products, are sold over the counter. 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
(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.
Customers should stop using the recalled ointments and return them to Allergan.
More information about the recall, including lot numbers of the products in question, is available on the FDA web site.
To report problems with Refresh, FML, and Blephamide ophthalmic ointments, contact MedWatch, the FDA’s safety information and adverse event reporting program:
- By telephone at 1-800-FDA-1088
- By fax at 1-800-FDA-0178
- With postage-paid FDA form 3500, available here
- Or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787