Why it was recalled
Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot # 21101Y, Exp. 11/30/2022
Where it was sold
Nationwide in the U.S.A.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0764-2022
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Mar 21, 2022
- FDA report date
- Apr 13, 2022
- Quantity
- 2,500 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Adamis Pharmaceuticals Corporation
Original FDA data
Every field from FDA enforcement report D-0764-2022, exactly as published.
Show all FDA fields
- City
- San Diego
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 89778
- Address
- 11682 El Camino Real Ste 300
- Code information
- Lot # 21101Y, Exp. 11/30/2022
- Postal code
- 92130-2092
- Report date
- Apr 13, 2022
- Product type
- Drugs
- Recall number
- D-0764-2022
- Classification
- Class I
- Recalling firm
- Adamis Pharmaceuticals Corporation
- Product quantity
- 2,500 cartons
- Termination date
- Feb 8, 2023
- Reason for recall
- Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the U.S.A.
- Recall initiation date
- Mar 21, 2022
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Apr 8, 2022