EPINEPHRINE Recall D-1014-2022
Description: Epinephrine Injection, USP, Single-Dose Auto-Injectors 0.15 mg, packaged in 2 count carton, Rx only, MFG: Mylan Pharma NDC 49502-101-02
EPINEPHRINE Recall D-1014-2022 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-1014-2022 |
Event ID | 89646 |
Brand | EPINEPHRINE |
Generic Name | EPINEPHRINE |
Manufacturer | EPINEPHRINE |
Original Package? | 1 |
Active Substance | EPINEPHRINE |
Drug Route | INTRAMUSCULAR |
Distribution | USA nationwide. |
Quantity | 30 packs |
Recall Reason | cGMP deviations: Temperature abuse |
Drug Classification | Class II |
Drug Code Info | 20220615 |
Product NDC | 49502-101 49502-102 |
Product NUI | N0000000209 N0000000245 N0000175552 |
Pharma Class (EPC) | alpha-Adrenergic Agonist [EPC] |
Pharma Class (CS) | Catecholamines [CS] |
Recall Initiation Date | 20220413 |
Report Date | 20220615 |
Classification Date | 20220609 |
Address | 9954 Maryland DriveDeep Run Iii Ste. 4000 Richmond, VA 23233 United States |
Recalling Firm | Mckesson Medical-Surgical Inc. Corporate Office |
Initial Notification | Letter |
Unique Ingredient Identifier | YKH834O4BH |
Drug Application Number | NDA019430 |
Structured Product Labeling (SPL ID) | 0feb46d8-aa36-407b-a846-dd81f76e16e8 |
Structured Product Labeling (SPL Set ID) | 778ac6ae-6bcb-47a4-bcb3-8dd0da9f8836 |
Similar To |