Potential Clogging of Anaphylaxis Med Prompts Class I Recall

Adamis Pharmaceuticals Corporation is recalling 4 lots of Symjepi (epinephrine) Injection prefilled single-dose syringes, citing potential clogging of the needle preventing the dispensing of epinephrine. The recall has been designated Class I, according to the April 13, 2022, US Food and Drug Administration (FDA) Enforcement Report. The classification suggests use of the affected product could cause serious adverse health consequences or death.

“If a person is experiencing an allergic reaction and/or anaphylaxis and is unable to access life-saving epinephrine due to the syringe malfunction, it can lead to life-threatening consequences including death,” Adamis Pharmaceuticals stated in a March 21, 2022, company announcement. “Although not confirmed to be related to the recall, there have been two different customer complaints on 3 syringes, regarding difficulty in dispensing the product, to date.”

The recall affects the following products, which were made in Belgium and distributed by US WorldMeds throughout the United States:

• Symjepi (epinephrine) Injection, .15 mg (.15 mg/.3 mL), 2 prefilled single-dose syringes per carton (NDC 78670-131-02), from lot 21101Y (Exp. 11/30/22); and
• Symjepi (epinephrine) Injection, .3 mg (.3 mg/.3 mL), 2 prefilled single-dose syringes per carton (NDC 78670-130-02), from lots 21041W (Exp. 8/31/22), 21081W (Exp. 11/30/22), and 21102W (Exp. 2/28/23).

Adamis Pharmaceuticals initiated the voluntary recall March 21, 2022. The FDA issued the Class I designation April 8, 2022.

Symjepi is a prescription medication indicated for the emergency treatment of allergic reactions, including anaphylaxis, to stinging and biting insects, allergen immunotherapy, foods, drugs, diagnostic testing substances, and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.