EPINEPHRINE Recall D-0764-2022
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.
EPINEPHRINE Recall D-0764-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0764-2022 |
| Event ID | 89778 |
| Brand | SYMJEPI |
| Generic Name | EPINEPHRINE |
| Manufacturer | EPINEPHRINE |
| Original Package? | 1 |
| Active Substance | EPINEPHRINE |
| Drug Route | INTRAMUSCULAR |
| Distribution | Nationwide in the U.S.A. |
| Quantity | 2,500 cartons |
| Recall Reason | Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine. |
| Drug Classification | Class I |
| Drug Code Info | 20220413 |
| Product NDC | 78670-130 78670-131 |
| Product NUI | N0000000209 N0000000245 N0000175552 |
| Pharma Class (EPC) | alpha-Adrenergic Agonist [EPC] |
| Pharma Class (CS) | Catecholamines [CS] |
| Recall Initiation Date | 20220321 |
| Report Date | 20220413 |
| Classification Date | 20220408 |
| Address | 11682 El Camino Real Ste 300 San Diego, CA 92130-2092 United States |
| Recalling Firm | Adamis Pharmaceuticals Corporation |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Unique Ingredient Identifier | YKH834O4BH |
| Drug Application Number | NDA207534 |
| Structured Product Labeling (SPL ID) | b81ff52b-5ce1-4794-8ac6-8195e6360f9d |
| Structured Product Labeling (SPL Set ID) | eeb2da6b-3fb3-48f6-bb62-ac3ad3b8fafa |
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