FDA recall D-0150-2025

Provepharm Inc. · Class II · drug

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

Reason for recall

Discoloration

Distribution

Nationwide within the United States

Key facts

Status
Ongoing
Initiation date
2024-11-22
Report date
2024-12-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Collegeville, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0150-2025