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 |
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