December 2021 FDA Recall Veklury by Gilead Sciences, Inc.
D-0299-2022 - Presence of Particulate Matter

This Class I drug recall was voluntarily initiated by Gilead Sciences, Inc. on December 3, 2021 for the product Veklury. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0299-2022

Reason for Recall
Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates.
Initiated
12-03-2021
Reported
01-05-2022
Quantity
53,473 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89153
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Gilead Sciences, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-25-2022
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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

Affected Packages Involved in this Recall

61958-2902-2 Veklury
61958-2901-2 Veklury