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
The recall encompasses all of the following batches, within expiry:
Product | Strength | NDC | Lot | Expiration |
SYMJEPI (epinephrine) Injection | 0.15 mg/0.3 mL | 78670-131-02 | 21101Y | |
0.3 mg/0.3 mL | 78670-130-02 | 21041W | ||
21081W | ||||
21102W |
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
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Adverse reactions or quality problems experienced with the use of this product may be reported to the
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the
Adamis Contacts:
Quality Compliance
858-361-6456
craigs@qualpartners.com
Investor Relations
Managing Director
ICR Westwicke
619.228.5886
robert.uhl@westwicke.com
SYMJEPI Photo 1
SYMJEPI
SYMJEPI Photo 2
SYMJEPI
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