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Allergan Recalls Eye Ointment

Recalls of pharmaceutical products are steadily on the rise, with record levels reached in 2014. The reasons for the recalls include packaging defects, product contamination, improper testing, or inherent safety issues that pose harm to patients.

The latest recall involves certain eye ointments manufactured by Allergen plc. Due to a defect in the product packaging, the medication can be contaminated upon opening it. This is Allergan’s fourth recall this year, suggesting that the company may be suffering quality control issues.

As detailed in the recall notice, the recall impacts specified batches of the REFRESH P.M. ®, REFRESH® Lacri-Lube®, FML® (fluorometholone ophthalmic ointment) 0.1%, Blephamide® (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2%. The specific lot numbers are available on the U.S. Food and Drug Safety Administration website.

Allergan initiated the recall after several consumers reported seeing small black particle when using the product. This particle is actually part of the cap, and can be created when the user unscrews the cap from the aluminum tube. This particle can be introduced into the product, which has been reported to result in the following: foreign body in eye, eye irritation, ocular discomfort, product contamination, superficial injury of the eye, eye pain, eye swelling, and blurred vision.

Allergan is advising consumers to cease using the defective products and return the medications to the manufacturer. Allergan is also reaching out to both retailers and wholesalers have received affected product batches in order to initiate the recall.