Drug Safety Alerts

SYMJEPI® Consumer-Level Recall

3/22/2022

On March 22, 2022, the U.S. Food and Drug Administration (FDA) published a consumer-level recall of multiple 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 manufactured by Adamis Pharmaceuticals Corporation and distributed by US WorldMeds (USWM). This recall is being issued due to the potential clogging of the needle preventing the dispensing of epinephrine.

This may represent a potential health hazard or safety risk to patients using product affected by this recall.

A list of the affected products and lot #s is provided HERE.

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. According to Adamis, 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. Adamis has advised that neither US WorldMeds nor Adamis Pharmaceuticals has received, or is aware of, any adverse events related to this recall.

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.

Adamis has advised that consumers who have SYMJEPI® (Epinephrine) Injection being recalled should stop using the products immediately and may either return or discard the recalled lots. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

CVS Caremark Response: CVS Caremark is in the process of contacting patients and prescribers to advise them of this recall. We are encouraging patients who are taking SYMJEPI® (Epinephrine) Injection to contact their prescriber.

For more information, please call US WorldMeds at (888) 900-8796 or e-mail questions at mailto:medinfo@usworldmeds.com Monday-Friday from 8:00 am to 4:00 pm ET. You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov.