Dihydroergotamine Mesylate Injection, solution for injection, USP, 1 mg/mL Ampules, Rx Only, Dist...

FDA Recall #D-0150-2025 — Class II — November 22, 2024

Recall #D-0150-2025 Date: November 22, 2024 Classification: Class II Status: Ongoing

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

Reason for Recall

Discoloration

Recalling Firm

Provepharm Inc. — Collegeville, PA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

2160 packs/5 ampules per pack = 10,800 ampules

Distribution

Nationwide within the United States

Code Information

Lot #: F9026F01, F9026F02, Exp. Date 12/2025

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated