Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gilead Sciences, Inc., Fos
Summary
The FDA issued a Class I for Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manu by Gilead Sciences, Inc.. Reason: Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates..
Details
Source
Drug Recall
External ID
D-0299-2022
Action Date
2022-01-05
Status
Terminated
Category
drug
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
Lot/Code Info: Lots: 2141001-1A, 2141002-1A, Exp. 01/2024
Quantity Affected: 53,473 vials
Reason for Recall
Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-03
Company
Foster City, CA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 51 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Gilead Sciences, Inc. has 11 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Gilead Sciences, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Gilead Sciences, Inc. have FDA actions?
Gilead Sciences, Inc. has 11 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0299-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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