SYMJEPI Epinephrine Injection Recalled for Defective Delivery System Nationwide
Adamis Pharmaceuticals is recalling 2,500 cartons of SYMJEPI (epinephrine injection) nationwide due to a defective delivery system that may clog the needle and prevent medication dispensing.
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 (Severe). Although no illnesses or injuries have been reported in the source text, the potential failure of critical medication delivery creates serious risk to patients.
Plain-English summary
Adamis Pharmaceuticals Corporation is recalling 2,500 cartons of SYMJEPI (epinephrine injection, USP) 0.15 mg due to a defective delivery system. The product was distributed nationwide in the United States. The affected lot is lot # 21101Y, with expiration date 11/30/2022.
The defect involves potential clogging of the needle that could prevent the dispensing of epinephrine when the device is used. The FDA classified this as a Class I recall, indicating a serious potential health risk.
The recalled product
- Product
- SYMJEPI (epinephrine injection, USP) 0.15 mg (0.15 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 78670-131-02.
- Manufacturer
- Adamis Pharmaceuticals Corporation
- Category
- Drug — Epinephrine Injection
- Affected units
- 2,500
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 (2)
- Lot # 21101Y
- Exp. 11/30/2022
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 →- SevereFDA Recalls SYMJEPI Epinephrine Injection for Potential Needle Clogging
FDA (Drugs) · 2022-04-13
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