Product Safety Recalls

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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0764-2022
Event ID89778
BrandSYMJEPI
Generic NameEPINEPHRINE
ManufacturerEPINEPHRINE
Original Package?1
Active SubstanceEPINEPHRINE
Drug RouteINTRAMUSCULAR
DistributionNationwide in the U.S.A.
Quantity2,500 cartons
Recall ReasonDefective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine.
Drug ClassificationClass I
Drug Code Info20220413
Product NDC78670-130 78670-131
Product NUIN0000000209 N0000000245 N0000175552
Pharma Class (EPC)alpha-Adrenergic Agonist [EPC]
Pharma Class (CS)Catecholamines [CS]
Recall Initiation Date20220321
Report Date20220413
Classification Date20220408
Address11682 El Camino Real Ste 300
San Diego, CA 92130-2092
United States
Recalling FirmAdamis Pharmaceuticals Corporation
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Unique Ingredient IdentifierYKH834O4BH
Drug Application NumberNDA207534
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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