Daiichi Sankyo subsidiary American Regent is launching a recall of three lots of generic epinephrine as it becomes one of the latest manufacturers to face headaches over particulate contamination in its drug products.
The product pull—which covers three U.S.-distributed batches of multidose epinephrine vials for injection—follows customer complaints of “leaking and cracked vials,” which in turn means American Regent can no longer assure the sterility of the products, the company said in a release.
Upon investigating the issue, American Regent said it also discovered the presence of particulate matter, which it identified as nylon, cellulosic, acrylic, polyethylene and glass.
Injecting a drug containing particulate matter can lead to serious problems like blockage and clotting of blood vessels, which can ultimately cause organ damage or even death, American Regent cautioned in its recall alert.
Injected particulates can also cause local vein irritation, as well as inflammatory and allergic reactions, and can aggravate preexisting infections, too.
As of Sept. 3, American Regent said it had not received any adverse event reports tied to the recall.
The epinephrine product under recall—used for emergency treatment of allergic reactions and anaphylaxis—was packaged in multi-dose vials that can be administered intravenously, into the muscle or under the skin by a physician. The three batches were shipped out across the U.S. and carried expiration dates from August of this year through next July, per the company’s announcement.
American Regent operates under the banner of the Daiichi Sankyo Group, also the parent of Japan-based innovative drugmaker Daiichi Sankyo. The company boasts two commercial business units, comprising hospital injectables and an iron franchise, according to its website.
American Regent is no stranger to particle contamination troubles, having dealt with a protracted spate of recalls prompted by the issue in the early 2010s.
Meanwhile, several other drugmakers encountered particulate issues this summer, with the likes of Fresenius Kabi, B. Braun and Baxter all issuing recalls over the course of August. In many instances, the recalled products were again intended for use within the hospital setting.