Drug 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.
D-0764-2022
Product summary
- Event
- Event 89778
- Status
- Terminated
- Classification
- Class I
- Quantity
- 2,500 cartons
- Official record key
drug-enforcement:D-0764-2022
Official wording
Reason: Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine.
Code information: Lot # 21101Y, Exp. 11/30/2022
Distribution pattern: Nationwide in the U.S.A.
Derived failure modes
-
Unknown
Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine.