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Recall Observatory FDA recall evidence

Drug product

Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA 94404, NDC 61958-2901-2

D-0005-2025

September 19, 2024

Class I

Product summary

Firm
Gilead Sciences, Inc.
Event
Event 95399
Status
Terminated
Classification
Class I
Quantity
105,000 vials
Official record key
drug-enforcement:D-0005-2025

Official wording

Reason: Presence of Particulate Matter: Presence of glass particle.

Code information: Lot: 47035CFA, Exp. 11/2025

Distribution pattern: Nationwide in the U.S.A.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter