FDA Recalls SYMJEPI Epinephrine Injection for Potential Needle Clogging
Adamis Pharmaceuticals is recalling SYMJEPI epinephrine injections due to potential needle clogging that may prevent medication delivery. The FDA has classified this as a Class I recall affecting nationwide distribution.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates a minimum severity score of 4 per the rubric. Although no illnesses or deaths are reported, the defect involves failure of an emergency life-saving medication system.
Plain-English summary
SYMJEPI (epinephrine injection, USP) 0.3 mg in pre-filled single-dose syringes is being recalled. The product is manufactured by Adamis Pharmaceuticals Corporation and distributed by USWM, LLC.
A defective delivery system may cause needle clogging that prevents the dispensing of epinephrine. The recall, classified as FDA Class I, affects 25,103 cartons distributed nationwide.
The affected lot numbers are 21041W (expiring 8/31/2022), 21081W (expiring 11/30/2022), and 21102W (expiring 2/28/2023). Individuals with affected units should check the lot number on their syringe and consult with their healthcare provider or pharmacist regarding replacement.
The recalled product
- Product
- SYMJEPI (epinephrine injection, USP) 0.3 mg, (0.3 mg/0.3 mL), Two Pre-Filled Single-Dose Syringes per carton, Rx Only, Manufactured for Adamis Pharmaceuticals Corp.; San Diego, CA 92130; Distributed by USWM, LLC., Louisville, KY 40241, Made in Belgium, NDC 78670-130-02
- Manufacturer
- Adamis Pharmaceuticals Corporation
- Hazard
- needle-clogging
- delivery-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot #: 21041W
- Exp. 8/31/2022
- 21081W
- Exp. 11/30/2022
- 21102W
- Exp. 2/28/2023
Distribution
Distributed nationwide across the United States.
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