Safety Report: SYMJEPI Injection Pre-Filled Single-Dose Syringes - recalled due to potential clogging of the needle, USA

United States

Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) is voluntarily recalling certain lots of SYMJEPI (epinephrine) Injection 0.15 mg (0.15 mg/0.3 mL) and 0.3 mg (0.3 mg/0.3 mL) Pre-Filled Single-Dose Syringes to the consumer level. The batches in the table below are being recalled due to the potential clogging of the needle preventing the dispensing of epinephrine. US WorldMeds (USWM) exclusively markets and distributes SYMJEPI in the United States, under license from Adamis, the NDA holder.

USWM will handle the entire recall process for Adamis, with Adamis oversight. SYMJEPI is manufactured and tested for Adamis by Catalent Belgium S.A. Risk Statement: 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. 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.

However, neither US WorldMeds nor Adamis Pharmaceuticals has received, or is aware of, any adverse events related to this recall. The recall encompasses all of the following batches, within expiry:

+ SYMJEPI (epinephrine) Injection.
-- Strength: 0.15 mg/0.3 mL. NDC: 78670-131-02. Lot: 21101Y. Expiration: 11/30/2022
-- Strength: 0.3 mg/0.3 mL. NDC: 78670-130-02. Lot | Expiration: 21041W | 8/31/2022. 21081W | 11/30/2022. 21102W | 2/28/2023

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 (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.

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.

Company name: Adamis Pharmaceuticals Corporation
Brand name: Adamis Pharmaceuticals Corporation
Product recalled: SYMJEPI (epinephrine) Injection 0.15 mg (0.15 mg/0.3 mL) and 0.3 mg (0.3 mg/0.3 mL) Pre-Filled Single-Dose Syringes
Reason of the recall: Potential clogging of the needle preventing the dispensing of epinephrine
FDA Recall date: March 22, 2022

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/adamis-pharmaceuticals-corporation-issues-nationwide-voluntary-recall-symjepir-epinephrine-injection