Dihydroergotamine Mesylate Injection, solution for injection, USP, 1 mg/mL Ampules, Rx Only, Distributed by: Provepharm
Summary
The FDA issued a Class II for Dihydroergotamine Mesylate Injection, solution for injection, USP, 1 mg/mL Ampul by Provepharm Inc.. Reason: Discoloration.
Details
Source
Drug Recall
External ID
D-0150-2025
Action Date
2024-12-25
Status
Ongoing
Category
drug
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/Code Info: Lot #: F9026F01, F9026F02, Exp. Date 12/2025
Quantity Affected: 2160 packs/5 ampules per pack = 10,800 ampules
Reason for Recall
Discoloration
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-22
Company
Collegeville, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 75 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Provepharm Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Provepharm Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Provepharm Inc. have FDA actions?
Provepharm Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0150-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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