FDA MedWatch - SYMJEPI (Epinephrine) Injection by Adamis Pharmaceuticals:

U.S. Food and Drug Administration sent this bulletin at 03/23/2022 08:55 AM EDT

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

TOPIC: SYMJEPI (Epinephrine) Injection by Adamis Pharmaceuticals: Recall - Due to Potential Manufacturing Defect

AUDIENCE: Patient, Health Professional, Risk Manager, Pharmacy, Allergy and Immunology

ISSUE: Adamis Pharmaceuticals Corporation is 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 due to the potential clogging of the needle preventing the dispensing of epinephrine.

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.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: 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.

RECOMMENDATIONS:

Patients and institutions that have products that are subject to this recall should stop using the products immediately and may either return or discard the recalled lots.
Patients with questions regarding this recall can contact the company.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report online.
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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