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

FDA Recall #D-0299-2022 — Class I — December 3, 2021

Recall #D-0299-2022 Date: December 3, 2021 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: investigation into a customer complaint confirmed the presence of glass particulates.

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

53,473 vials

Distribution

Nationwide in the USA

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated