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
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.