A prominent pharmaceutical company is issuing a recall due to the discovery of potentially dangerous particulate matter.
Allergan, a Dublin, Ireland company with a U.S. headquarters in Parsippany-Troy Hills, NJ, is recalling specific lots of four different drugs in response to customer complaints which reported a small black particle at the time of use. This black particle, which is part of the cap, can be created by the action of unscrewing the cap from the aluminum tube, and potentially introduced into the product. The four drugs are REFRESH Lacri-Lube, REFRESH P.M., FML, and Blephamide.
Reported adverse events include the following: Foreign Body in Eye (12 instances), Eye Irritation (2), Ocular Discomfort (2), Product Contamination (2), Superficial Injury of Eye (2), Eye Pain (1), Eye Swelling (1) and Vision Blurred (1). All figures are reported by the U.S. Food and Drug Administration (FDA).
Specific lots are being voluntarily recalled in the interest of patient safety. Please contact your physician or healthcare provider if you have any of these symptoms when using these products. The lot number and expiration date may be found on the bottom flap of the carton with the safety seal and on the crimp seal of the product tube.
For a list of specific information on the recalled lots, visit the FDA press release.
Allergan is contacting retailers and wholesalers who have been shipped affected product lots to initiate the recall and is informing them of the steps needed to return affected product. The company is asking consumers who currently have product from any of the affected lots to stop using the product and return it to Allergan.
Customers with questions can contact (800) 811-4148.