Why it was recalled
Discoloration
Product 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
Lot numbers, UPCs & expiration codes
Lot #: F9026F01, F9026F02, Exp. Date 12/2025
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0150-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Nov 22, 2024
- FDA report date
- Dec 25, 2024
- Quantity
- 2160 packs/5 ampules per pack = 10,800 ampules
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Provepharm Inc.
Original FDA data
Every field from FDA enforcement report D-0150-2025, exactly as published.
Show all FDA fields
- City
- Collegeville
- State
- PA
- Status
- Ongoing
- Country
- United States
- Event ID
- 95772
- Address
- 100 Springhouse Dr Ste 105
- Code information
- Lot #: F9026F01, F9026F02, Exp. Date 12/2025
- Postal code
- 19426-4709
- Report date
- Dec 25, 2024
- Product type
- Drugs
- Recall number
- D-0150-2025
- Classification
- Class II
- Recalling firm
- Provepharm Inc.
- Product quantity
- 2160 packs/5 ampules per pack = 10,800 ampules
- Reason for recall
- Discoloration
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Nov 22, 2024
- Initial firm notification
- Letter
- Center classification date
- Dec 16, 2024