Allergan recalls Refresh, FML, Blephamide eye drops
Allergan recently issued a voluntary U.S. recall of its Refresh Lacri-Lube, Refresh P.M., FML (fluorometholone ophthalmic ointment) 0.1%, and Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment) 10%/0.2% due to customer complaints of small black particles at the time of use.
Dublin-Allergan recently issued a voluntary U.S. recall of its Refresh Lacri-Lube, Refresh P.M., FML (fluorometholone ophthalmic ointment) 0.1%, and Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment) 10%/0.2% due to customer complaints of small black particles at the time of use.
According to Allergan, the black particle is part of the cap and can be created by the action of unscrewing the cap from the aluminum tube and potentially introduced into the product.
The company says the reported adverse events include:
• Foreign body in the eye
• Eye irritation
• Ocular discomfort
• Product contamination
• Superficial eye injury
• Eye pain
• Eye swelling
• Blurred vision
Allergan is recalling specific lots and does not affect any other Refresh or Allergan products. To see a complete list of the recalled lot numbers, CLICK HERE. The lot number and expiration date can be found on the bottom flap of the carton with the safety seal and on the crimp seal of the product tube.
If a patient experiences eye pain, swelling, ocular discomfort or irritation after using any of the recalled products, Allergan says the patient should contact a healthcare provider.
For any questions regarding product returns, contact GENCO at 877-674-2087 from 7 a.m. to 5 p.m. CST. For questions regarding credit or reimbursements, contact Allergan at 1-800-811-4148 from 7 a.m. to 5 p.m. PST.
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