Drug recall notice for Symjepi (epinephrine) injection

A physician holds a vial of pills while taking notes at a computer.

To assist you in the care of your patients, we would like to alert you to the recall of 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) prefilled, single-dose syringes to the consumer level on March 22, 2022.1 We recommend you review your medical records and contact all patients for whom you have prescribed this medication to warn them of the recall.

Symjepi is intended for immediate administration in patients who are at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. The drug manufacturer, Adamis Pharmaceuticals Corp., is voluntarily recalling this product due to the potential clogging of the needle, which prevents the dispensing of life-saving epinephrine.

Other lot numbers of Symjepi are unaffected and readily available.

Medications included in this recall

Product name NDC number Lot number Expiration date Symjepi (epinephrine) injection 21101Y 11/30/2022 0.15 mg (0.15 mg/0.3 mL) 78670-131-02 21041W 8/31/2022 0.3 mg (0.3 mg/0.3 mL) 78670-130-02 21081W 11/30/2022 21102W 2/28/2023

Information for providers:1

  • We have sent a letter to your Humana-covered patients who have had a claim for Symjepi and asked them to contact their physicians or healthcare providers if their medication is included in the recall and if they have experienced problems that may be related to using these drug products.
  • For questions regarding this recall, please contact USWorldMeds at 888-900-8796, Monday – Friday, 8 a.m. – 4 p.m., Eastern time, or email questions to medinfo@usworldmeds.com.
  • Patients may report adverse reactions or quality problems experienced with the use of this product to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
    • Online: Complete and submit the report.
      • Select “Consumer/Patient (FDA Form 3500B).”
    • Regular mail or fax: Download the form.
      • Select “Form FDA 3500B – Voluntary Reporting for Consumers” and submit by mail to the address on the form or by fax to 800-FDA-0178 (332-0178).

Reference:

  1. “Adamis Pharmaceuticals Corporation Issues Nationwide Voluntary Recall of SYMJEPI® (Epinephrine) Injection for Potential Manufacturing Defect,” U.S. Food and Drug Administration, last accessed March 28, 2022, www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/adamis-pharmaceuticals-corporation-issues-nationwide-voluntary-recall-symjepir-epinephrine-injection.