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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Affected units
- 25,103
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.
Part of a larger recall action
This product is one of 2 recalled by Adamis Pharmaceuticals Corporation under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Adamis Pharmaceuticals Corporation
See all →- SevereSYMJEPI Epinephrine Injection Recalled for Defective Delivery System Nationwide
FDA (Drugs) · 2022-04-13
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