DIHYDROERGOTAMINE MESYLATE Recall D-0150-2025
Description: Dihydroergotamine Mesylate Injection, solution for injection, USP, 1 mg/mL Ampules, Rx Only, Distributed by: Provepharm Inc. 100 Springhouse Drive Suite 105, Collegeville, PA 19426, NDC 81284-411-05
DIHYDROERGOTAMINE MESYLATE Recall D-0150-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0150-2025 |
| Event ID | 95772 |
| Brand | DIHYDROERGOTAMINE MESYLATE |
| Generic Name | DIHYDROERGOTAMINE MESYLATE |
| Manufacturer | DIHYDROERGOTAMINE MESYLATE |
| Original Package? | 1 |
| Active Substance | DIHYDROERGOTAMINE MESYLATE |
| Drug Route | INTRAMUSCULAR |
| Distribution | Nationwide within the United States |
| Quantity | 2160 packs/5 ampules per pack = 10,800 ampules |
| Recall Reason | Discoloration |
| Drug Classification | Class II |
| Drug Code Info | 20241225 |
| Product NDC | 81284-411 |
| Drug UPC | 0381284411059 0381284411103 |
| Recall Initiation Date | 20241122 |
| Report Date | 20241225 |
| Classification Date | 20241216 |
| Address | 100 Springhouse Dr Ste 105 Collegeville, PA 19426-4709 United States |
| Recalling Firm | Provepharm Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 81AXN7R2QT |
| Drug Application Number | ANDA212046 |
| Structured Product Labeling (SPL ID) | 266a0914-df98-c5f3-e063-6394a90a95c5 |
| Structured Product Labeling (SPL Set ID) | 40b9ba9e-436e-444e-b078-01b12bb57ea7 |
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