The Recall Desk
SevereFDA (Drugs)·D-0764-2022·Announced 2022-04-13

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.

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 (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
Hazard
  • needle-clogging
  • medication-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 (2)

  • Lot # 21101Y
  • Exp. 11/30/2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same category