Dihydroergotamine Mesylate Injection, Solution
FDA Recall NDC 81284-411
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Dihydroergotamine Mesylate (NDC 81284-411). A significant event, classified as Class II, was initiated on Nov 22, 2024 by Provepharm Inc.. The reported reason for this action was: "Discoloration"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Discoloration
Nov 22, 2024
Dec 25, 2024
2160 packs/5 ampules per pack = 10,800 ampules
Recall Profile & Regulatory Data
Event ID
95772
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Provepharm Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
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
Batch or Lot Expiration Information
Lot# : F9026F01, F9026F02, Exp. Date 12/2025
Affected Packages Involved in this Recall
81284-411-00Product
81284-411-05Product
81284-411-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
