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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-0299-2022

December 03, 2021

Class I

Product summary

Firm
Gilead Sciences, Inc.
Event
Event 89153
Status
Terminated
Classification
Class I
Quantity
53,473 vials
Official record key
drug-enforcement:D-0299-2022

Official wording

Reason: Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates.

Code information: Lots: 2141001-1A, 2141002-1A, Exp. 01/2024

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter