Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gil...

FDA Recall #D-0005-2025 — Class I — September 19, 2024

Recall #D-0005-2025 Date: September 19, 2024 Classification: Class I Status: Terminated

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

Reason for Recall

Presence of Particulate Matter: Presence of glass particle.

Recalling Firm

Gilead Sciences, Inc. — Foster City, CA

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

105,000 vials

Distribution

Nationwide in the U.S.A.

Code Information

Lot: 47035CFA, Exp. 11/2025

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated