D-0150-2025Class II

Provepharm Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

Provepharm Inc.

Product type

Drug

Status

Ongoing

Report date

2024-12-25

Distribution

Nationwide within the United States

Firm state

Product quantity

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

Initiated by

Voluntary: Firm initiated

Reason for recall

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

Code / lot info

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

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →