Adamis Pharmaceuticals Corp issued a recall of certain lots of Symjepi (epinephrine) Injection prefilled single-dose syringes due to the potential clogging of the needle preventing the dispensing of epinephrine, according to an FDA alert.
The specific Symjepi syringes being recalled contain the following doses: 0.15 mg (0.15 mg/0.3 mL) and 0.3 mg (0.3 mg/0.3 mL). The FDA recommends that patients and institutions stop using the recalled products immediately and to contact the company to return or exchange.
|Symjepi (epinephrine) Injection||0.15 mg/0.3 mL||78670-131-02||21101Y||11/30/2022|
|0.3 mg/0.3 mL||78670-130-02||21041W||8/31/2022|
The FDA noted that the products are packaged in 2-count Pre-Filled Single-Dose Syringes per carton and were distributed nationwide in the USA and directly to customers and/or medical facilities. The products can be identified by the label containing the US WorldMeds name and logo pictured on the cartons below.
The agency warned that the inability to access epinephrine due to a syringe malfunction can lead to life threatening consequences including death for patients experiencing an allergic reaction and/or anaphylaxis. The FDA noted the company has not received nor is aware of any adverse events related to this recall. “Although not confirmed to be related to the recall, there have been two different customer complaints on three syringes, regarding difficulty in dispensing the product, to date,” it wrote in the alert.
According to the alert, Symjepi is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets, and fire ants) and biting insects (eg, triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (eg, radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.
More information on the Symjepi recall is available on the FDA website.