Recall Enforment Report D-0299-2022

Drug Recall Enforcement Report Class I voluntary initiated by Gilead Sciences, Inc., originally initiated on 12-03-2021 for 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 The product was recalled due to presence of particulate matter: investigation into a customer complaint confirmed the presence of glass particulates.. The product was distributed nationwide and the recall is currently terminated.

Field Name Field Value
Event ID 89153 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number D-0299-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification 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. What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern Nationwide in the USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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. What is the Reason for Recall?
Information describing how the product is defective.
Product Quantity 53,473 vials Product Quantity
The amount of product subject to recall.
Voluntary Mandated Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date 01-05-2022
Recall Initiation Date 12-03-2021 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.
Termination Date 07-25-2022 What is the Date Terminated?
The date that FDA terminated the recall.
Initial Firm Notification Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type Drugs
Recalling Firm Gilead Sciences, Inc.
Code Info Lots: 2141001-1A, 2141002-1A, Exp. 01/2024 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages 61958-2902-2; 61958-2901-2
Status Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
61958-2901Veklury RemdesivirInjection, Powder, Lyophilized, For SolutionIntravenousGilead Sciences, Inc.Human Prescription Drug
61958-2902Veklury RemdesivirInjectionIntravenousGilead Sciences, Inc.Human Prescription Drug