Medications & Supplements/Prescription Drugs

SYMJEPI Epinephrine Injections Recalled for Potential Needle Clogging

Agency Publication Date: April 1, 2022

Summary

Adamis Pharmaceuticals Corporation is recalling SYMJEPI (epinephrine injection, USP) 0.3 mg and 0.15 mg pre-filled single-dose syringes because the needle may be clogged. This defect could prevent the syringe from dispensing the medication during an emergency. Approximately 27,603 cartons of these products, which are used to treat severe allergic reactions (anaphylaxis), are affected by this recall. No incidents or injuries have been reported to date.

Risk

A clogged needle can prevent a patient from receiving a life-saving dose of epinephrine during a severe allergic reaction. Failure to deliver the medication could lead to serious illness or death during an emergency.

What You Should Do

This recall involves SYMJEPI (epinephrine injection, USP) 0.3 mg and 0.15 mg pre-filled single-dose syringes sold in cartons containing two syringes.
Check your SYMJEPI 0.3 mg (NDC 78670-130-02) for lot numbers 21041W (Exp. 8/31/2022), 21081W (Exp. 11/30/2022), or 21102W (Exp. 2/28/2023).
Check your SYMJEPI 0.15 mg (NDC 78670-131-02) for lot number 21101Y (Exp. 11/30/2022).
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: SYMJEPI (epinephrine injection, USP) 0.3 mg (0.3 mg/0.3 mL)

Variants: 0.3 mg, 0.3 mg/0.3 mL, Pre-Filled Single-Dose Syringes

Lot Numbers:

21041W (Exp. 8/31/2022)

21081W (Exp. 11/30/2022)

21102W (Exp. 2/28/2023)

NDC:

78670-130-02

Quantity: 25,103 cartons

Product: SYMJEPI (epinephrine injection, USP) 0.15 mg (0.15 mg/0.3 mL)

Variants: 0.15 mg, 0.15 mg/0.3 mL, Pre-Filled Single-Dose Syringes

Lot Numbers:

21101Y (Exp. 11/30/2022)

NDC:

78670-131-02

Quantity: 2,500 cartons

Product Images

“SYMJEPI (epinephrine injection) USP 0.3 mg, (0.3 mg/0.3 mL)”

“SYMJEPI (epinephrine injection) USP 0.15 mg, (0.15 mg/0.3 mL)”

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89778

Status: Resolved

Manufacturer: Adamis Pharmaceuticals Corporation

Sold By: Pharmacies nationwide; USWM, LLC.

Manufactured In: Belgium, United States

Units Affected: 2 products (25,103 cartons; 2,500 cartons)

Distributed To: Nationwide

Agency Last Updated: April 8, 2022

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall involves SYMJEPI (epinephrine injection, USP) 0.3 mg and 0.15 mg pre-filled single-dose syringes sold in cartons containing two syringes.

Check your SYMJEPI 0.3 mg (NDC 78670-130-02) for lot numbers 21041W (Exp. 8/31/2022), 21081W (Exp. 11/30/2022), or 21102W (Exp. 2/28/2023).

Check your SYMJEPI 0.15 mg (NDC 78670-131-02) for lot number 21101Y (Exp. 11/30/2022).

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: SYMJEPI (epinephrine injection, USP) 0.3 mg (0.3 mg/0.3 mL)

Variants: 0.3 mg, 0.3 mg/0.3 mL, Pre-Filled Single-Dose Syringes

Lot Numbers:

21041W (Exp. 8/31/2022)

21081W (Exp. 11/30/2022)

21102W (Exp. 2/28/2023)

NDC:

78670-130-02

Quantity: 25,103 cartons

Product: SYMJEPI (epinephrine injection, USP) 0.15 mg (0.15 mg/0.3 mL)

Variants: 0.15 mg, 0.15 mg/0.3 mL, Pre-Filled Single-Dose Syringes

Lot Numbers:

21101Y (Exp. 11/30/2022)

NDC:

78670-131-02

Quantity: 2,500 cartons

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89778

Status: Resolved

Manufacturer: Adamis Pharmaceuticals Corporation

Sold By: Pharmacies nationwide; USWM, LLC.

Manufactured In: Belgium, United States

Units Affected: 2 products (25,103 cartons; 2,500 cartons)

Distributed To: Nationwide

Agency Last Updated: April 8, 2022