FDA Recall D-0150-2025
Provepharm Inc. · Collegeville, PA
Class II Ongoing 538 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
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
Reason for recall
Discoloration
Recall record
- Recall number
D-0150-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide within the United States
- Recall initiated
- 2024-11-22
- Classified by FDA Center
- 2024-12-16
- FDA published
- 2024-12-25
- Recalling firm
- Provepharm Inc.
- Firm location
- Collegeville, PA
Drug identification
- Brand name(s)
- DIHYDROERGOTAMINE MESYLATE
- Generic name(s)
- DIHYDROERGOTAMINE MESYLATE
- Manufacturer(s)
- Provepharm Inc.
- NDC(s)
81284-411- Route(s)
- INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.