EPINEPHRINE Recall D-1022-2022
Description: Adrenalin (epinephrine injection, USP) 30 mg/30 mL (1mg/mL), 30 mL multiple dose vial, Rx only, MFG: Par Pharma, NDC 42023-168-01
EPINEPHRINE Recall D-1022-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1022-2022 |
| Event ID | 89646 |
| Brand | ADRENALIN |
| Generic Name | EPINEPHRINE |
| Manufacturer | EPINEPHRINE |
| Original Package? | 1 |
| Active Substance | EPINEPHRINE |
| Drug Route | INTRAMUSCULAR |
| Distribution | USA nationwide. |
| Quantity | 58 cartons |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 42023-159 42023-168 |
| 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 | NDA204200 |
| Structured Product Labeling (SPL ID) | 79e5cb81-15ee-45f9-86c6-ece4bd8362d9 |
| Structured Product Labeling (SPL Set ID) | 3b7a4364-668d-4eb2-a20c-04adc35aabe4 |
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