A timely injection of epinephrine can save the life of a person experiencing an allergic reaction. But what if the syringe is jammed? Now, a U.S. company is recalling its version of the critical medicine after reports of glitches.
Adamis Pharmaceuticals is voluntarily recalling four lots of its epinephrine injection, sold under the brand name Symjepi, because of concerns that clogs in needles can prevent the proper dispensing of the medicine, according to an FDA alert posted Tuesday.
The current withdrawal includes one lot of the pre-filled single-dose syringe at the 0.15 mg strength and three lots at the 0.3 mg dose. It comes after two different customers complained about difficulty to inject Symjepi for three syringes, Adamis noted.
As the FDA points out, failure to access epinephrine during an allergic reaction can have life-threatening consequences. Adamis and its marketing partner US WorldMeds have not received any side effects reports related to the recall, Adamis said.
US WorldMeds has been the marketer and distributor of Symjepi in the U.S. since mid-2020, when Adamis took back the rights from Novartis’ Sandoz and reassigned them to its new partner. US WorldMeds has its name and logo on the product labeling, and the New York pharma will handle the recall for Adamis.
CDMO giant Catalent’s Belgium chapter helps Adamis manufacture Symjepi, Adamis said. According to Catalent, the Brussels facility is its flagship European syringe filling facility with more than 70 years of manufacturing experience in biologics and sterile injectables. The unit has syringe filling capacities to churn out more than 175 million units per year, the company’s website shows.
Symjepi scored its first FDA approval in 2017. A year later, the agency endorsed a low-dose option.
This isn’t the first epinephrine product recall in recent years. Back in 2015, Sanofi recalled all doses of its epinephrine autoinjector, known as Auvi-Q in the U.S., after reports of malfunctions.
Then in 2020, FDA alerted the public of a potential problem with the epinephrine auto-injector sold by Amneal Pharmaceuticals’ Impax Laboratories. The issue at the time involved some devices missing the yellow “stop collars,” which could lead to the delivery of a double dose of epinephrine to a patient.
Mylan, known now as Viatris, also worked through a global recall for its original EpiPen back in 2017. The EpiPen malfunction was much more serious at that time, as two customers reported failures—not difficulties—in activating the epinephrine pen during emergencies.