Recalls / Class II
Class IID-0150-2025
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
- Brand name
- Dihydroergotamine Mesylate
- Generic name
- Dihydroergotamine Mesylate
- Active ingredient
- Dihydroergotamine Mesylate
- Route
- Intramuscular, Intravenous, Subcutaneous
- NDC
- 81284-411
- FDA application
- ANDA212046
- Affected lot / code info
- Lot #: F9026F01, F9026F02, Exp. Date 12/2025
Why it was recalled
Discoloration
Recalling firm
- Firm
- Provepharm Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 100 Springhouse Dr Ste 105, Collegeville, Pennsylvania 19426-4709
Distribution
- Quantity
- 2160 packs/5 ampules per pack = 10,800 ampules
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2024-11-22
- FDA classified
- 2024-12-16
- Posted by FDA
- 2024-12-25
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0150-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.