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Recall Observatory FDA recall evidence

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

D-0150-2025

November 22, 2024

Class II

Product summary

Firm
Provepharm Inc.
Event
Event 95772
Status
Ongoing
Classification
Class II
Quantity
2160 packs/5 ampules per pack = 10,800 ampules
Official record key
drug-enforcement:D-0150-2025

Official wording

Reason: Discoloration

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

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Discoloration