August 25, 2015
Allergan Issues Voluntary Nationwide Recall In The U.S. Of Specific Lots Of REFRESH® Lacri-Lube®, REFRESH P.M. ®, FML® 0.1%, and Blephamide® 10%/0.2% For Particulate Matter
Allergan is voluntarily recalling certain lots of various ophthalmic 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 in a news release posted on the website of the US Food and Drug Administration (FDA). Unscrewing the cap from the aluminum tube can create the particle. Users run the risk of the particle making its way into the ointment.
Adverse events reported by customers include foreign bodies in the eye, superficial eye injury, pain, 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
- 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.
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 website.
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; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.