The US Food and Drug Administration (FDA) has announced that Allergan PLC, based in Dublin, Ireland, has issued a voluntary recall of select lots of the following ophthalmic ointments that were distributed in the USA:
- REFRESH® Lacri-Lube®, 3.5g and 7.0g (for dry eyes)
- REFRESH PM®, 3.5 g (for dry eyes)
- Fluorometholone (FML®) 0.1%, 3.5g (sterile, topical, anti-inflammatory agent)
- Blephamide (Sulfacetamide Sodium And Prednisolone Acetate, (USP) 10%/0.2%, 3.5g (sterile antibacterial and corticosteroid combination).
The ophthalmic ointments are being recalled for the presence of black particulate matter reported by several customers at the time of use. The black particles are believed to have dislodged from the cap in the process of opening the ointment tubes. Consumers have reported adverse events such as:
- Foreign body in the eye
- Eye irritation
- Swelling of the eye
- Ocular discomfort
- Superficial injury to the eye
- Eye pain
- Blurred vision
- Contamination of the product.
Consumers who have used any of the above products and have symptoms listed above are requested to contact their physicians or healthcare providers.
The Company is requesting customers who have the products from the affected lots to stop using them and return the products to Allergan.
Useful contact information:
GENCO (for product returns): 1-877-674-2087 (7am to 5pm, CST)
Allergan (credits and reimbursements): 1-800-811-4148 (7am to 5pm, PST)
Allergan (medical inquiries): 1-800-433-8871; option 2 (8am-5pm, PST)
Adverse events/complaints: 1-800-624-4261; option 3 (8am-5pm, CST)
Note: Specific lot numbers and expiration dates are available on the FDA website given under ‘Primary Reference.’
U.S. Food and Drug Administration. (n.d.). Retrieved August 25, 2015, from http://www.fda.gov/Safety/Recalls/ucm459485.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery