GLUCAGON HYDROCHLORIDE Recall D-1038-2022
Description: Glucagen (glucagon) for injection, packaged in a 10-count box, (10 vials each containing 1 mg per vial), Rx only, MFG: Boehringer Mannheim, NDC 0597-0053-45
GLUCAGON HYDROCHLORIDE Recall D-1038-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1038-2022 |
| Event ID | 89646 |
| Brand | GLUCAGEN |
| Generic Name | GLUCAGON HYDROCHLORIDE |
| Manufacturer | GLUCAGON HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | GLUCAGON HYDROCHLORIDE |
| Drug Route | INTRAMUSCULAR |
| Distribution | USA nationwide. |
| Quantity | 1 carton/10 vials per carton |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 0597-0053 0597-0260 |
| 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 | 1H87NVF4DB |
| Drug Application Number | NDA020918 |
| Structured Product Labeling (SPL ID) | 6f81fe64-66cb-4532-8fd0-932979b89b84 |
| Structured Product Labeling (SPL Set ID) | ff16e4b1-3668-4cb4-91a4-77ee509cd6f6 |
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