D-0150-2025 Class II Ongoing

Recalled by Provepharm Inc. — Collegeville, PA

FDA drug recall D-0150-2025 was initiated by Provepharm Inc. on November 22, 2024 and is designated Class II. Reason for recall: Discoloration The recall status is ongoing. Affected quantity: 2160 packs/5 ampules per pack = 10,800 ampules.

Recall Details

Product Type
Drugs
Report Date
December 25, 2024
Initiation Date
November 22, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2160 packs/5 ampules per pack = 10,800 ampules

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

Distribution Pattern

Nationwide within the United States

Code Information

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