Adamis Pharmaceuticals is voluntarily recalling certain lots of Symjepi® (epinephrine) Injection 0.15mg (0.15mg/0.3mL) and 0.3mg (0.3mg/0.3mL) prefilled single-dose syringes due to potential clogging of the needle preventing the dispensing of epinephrine.
Symjepi is indicated for the emergency treatment of allergic reactions (Type 1), including anaphylaxis to stinging and biting insects, allergen immunotherapy, foods, drugs, diagnostic testing substances and other allergens, as well as idiopathic or exercise-induced anaphylaxis.
The recall applies to the following batches:
- Symjepi Injection 0.15mg/0.3mL; NDC Number 78670-131-02; Lot Number 21101Y; Expiration Date 11/30/2022;
- Symjepi Injection 0.3mg/0.3mL; NDC Number 78670-130-02; Lot Number 21041W; Expiration Date 8/31/2022;
- Symjepi Injection 0.3mg/0.3mL; NDC Number 78670-130-02; Lot Number 21081W; Expiration Date 11/30/2022;
- Symjepi Injection 0.3mg/0.3mL; NDC Number 78670-130-02; Lot Number 21102W; Expiration Date 2/28/2023.
Though not specifically associated with this recall, there have been 2 customer complaints related to issues with dispensing the medication. To date, there have been no confirmed reports of adverse events related to this recall.
Adverse reactions or quality problems should be reported to the Food and Drug Administration’s MedWatch program.
Adamis Pharmaceuticals Corporation issues nationwide voluntary recall of Symjepi® (epinephrine) injection for potential manufacturing defect. News release. Adamis Pharmaceuticals Corporation. Accessed March 22, 2022. https://www.globenewswire.com/news-release/2022/03/21/2407082/32832/en/Adamis-Pharmaceuticals-Corporation-Issues-Nationwide-Voluntary-Recall-of-SYMJEPI-epinephrine-Injection-for-Potential-Manufacturing-Defect.html