Product Safety Recalls

Product Recall Tracker

EPINEPHRINE Recall D-1012-2022

Description: EPI-Pen Jr, 2-PAK, (epinephrine injection, USP) Single-Dose Auto-Injectors 0.15 mg, packaged in 2 count carton, Rx only, MFG: Mylan Pharma, NDC 49502-501-02

EPINEPHRINE Recall D-1012-2022 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-1012-2022
Event ID89646
Original Package?1
Active SubstanceEPINEPHRINE
DistributionUSA nationwide.
Quantity4 cartons/2 auto injectors each
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC49502-500 49502-501
Product NUIN0000000209 N0000000245 N0000175552
Pharma Class (EPC)alpha-Adrenergic Agonist [EPC]
Pharma Class (CS)Catecholamines [CS]
Recall Initiation Date20220413
Report Date20220615
Classification Date20220609
Address9954 Maryland DriveDeep Run Iii Ste. 4000
Richmond, VA 23233
United States
Recalling FirmMckesson Medical-Surgical Inc. Corporate Office
Initial Notification Letter
Unique Ingredient IdentifierYKH834O4BH
Drug Application NumberNDA019430
Structured Product Labeling (SPL ID)8bf28dc2-c460-4809-928b-95bac5f21050
Structured Product Labeling (SPL Set ID)7560c201-9246-487c-a13b-6295db04274a
Similar To

© 2021 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied. is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.