November 2024 FDA Recall Dihydroergotamine Mesylate by Provepharm Inc.
D-0150-2025 - Discoloration
This Class II drug recall was voluntarily initiated by Provepharm Inc. on November 22, 2024 for the product Dihydroergotamine Mesylate. The FDA reported the reason for recall as discoloration. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0150-2025
Discoloration
11-22-2024
12-25-2024
2160 packs/5 ampules per pack = 10,800 ampules
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Provepharm Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : F9026F01, F9026F02, Exp. Date 12/2025
