EPINEPHRINE Recall D-0993-2022
Description: EPI-PEN 2-PAK (epinephrine injection, USP), Single-Dose Auto-Injectors 0.3 mg, Rx only, Manufactured for: Mylan Specialty LP., NDC 49502-500-02
EPINEPHRINE Recall D-0993-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0993-2022 |
| Event ID | 89646 |
| Brand | EPIPEN |
| Generic Name | EPINEPHRINE |
| Manufacturer | EPINEPHRINE |
| Original Package? | 1 |
| Active Substance | EPINEPHRINE |
| Drug Route | INTRAMUSCULAR |
| Distribution | USA nationwide. |
| Quantity | 5 cartons |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 49502-500 49502-501 |
| 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) | 8bf28dc2-c460-4809-928b-95bac5f21050 |
| Structured Product Labeling (SPL Set ID) | 7560c201-9246-487c-a13b-6295db04274a |
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