DANTROLENE SODIUM Recall D-1081-2022
Description: Revonto (dantrolene sodium for injection), 20 mg/vial, 6-count box, Rx only, MFG: US WorldMeds, Inc., NDC 78670-003-67
DANTROLENE SODIUM Recall D-1081-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1081-2022 |
| Event ID | 89646 |
| Brand | REVONTO |
| Generic Name | DANTROLENE SODIUM |
| Manufacturer | DANTROLENE SODIUM |
| Original Package? | 1 |
| Active Substance | DANTROLENE SODIUM |
| Drug Route | INTRAVENOUS |
| Distribution | USA nationwide. |
| Quantity | 49 cartons/6 vials each |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 78670-003 |
| 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 | 287M0347EV |
| Drug Application Number | ANDA078378 |
| Structured Product Labeling (SPL ID) | 12725182-c78c-43f3-8a0e-3943446ee3b6 |
| Structured Product Labeling (SPL Set ID) | f1650487-32bd-4017-b9c2-b38829a531af |
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