Veklury
FDA Recall NDC 61958-2902
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
The FDA has identified 2 recorded enforcement report(s) associated with Veklury (NDC 61958-2902). A significant event, classified as Class I, was initiated on Sep 19, 2024 by Gilead Sciences, Inc.. The reported reason for this action was: "Presence of Particulate Matter: Presence of glass particle."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class I Terminated
Presence of Particulate Matter: Presence of glass particle.
Sep 19, 2024
Oct 09, 2024
105,000 vials
Recall Profile & Regulatory Data
Event ID
95399
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Gilead Sciences, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S.A.
Termination Date
Jul 29, 2025
Product Description
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
Batch or Lot Expiration Information
Lot# Lot: 47035CFA, Exp. 11/2025
Affected Packages Involved in this Recall
61958-2902-2Product
61958-2901-2Product
Class I Terminated
Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates.
Dec 03, 2021
Jan 05, 2022
53,473 vials
Recall Profile & Regulatory Data
Event ID
89153
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Gilead Sciences, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Jul 25, 2022
Product Description
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
Batch or Lot Expiration Information
Lot# Lots: 2141001-1A, 2141002-1A, Exp. 01/2024
Affected Packages Involved in this Recall
61958-2902-2Product
61958-2901-2Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
