Class I · High risk
Veklury (remdesivir)
Presence of Particulate Matter: Presence of glass particle.
Veklury (remdesivir)
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
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
Affected NDC
61958-2901-02
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Veklury remdesivir NDC 61958-2901 |
100 mg/1 | Injection, Powder, Lyophilized, for Solution Intravenous |
Gilead Sciences, Inc. | Rx |
- Recalling firm
- Gilead Sciences, Inc.
- NDC code
- 61958-2901-2
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0299-2022 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Gilead Sciences, Inc.
All 2021 recalls
Class II · Moderate risk
Emtriva (emtricitabine)
Defective Container; leaking around the cap
Class III · Low risk
Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate)
Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates.
Class III · Low risk
Atripla
Presence of Foreign Substance: Red Silicone Rubber Particulates are Present in Drug.
Other particulate / foreign matter recalls from 2021
All particulate / foreign matter recalls
Class II · Moderate risk
Metoprolol Tartrate Tablets
Complaint received of foreign matter (metal) embedded in tablet.
Class I · High risk
Cubicin (daptomycin for injection)
Presence of Particulate Matter: Identified as Glass Particles
Class II · Moderate risk
Ezetimibe and Simvastatin Tablets
Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
Class II · Moderate risk
Dr. Reddy's Ezetimibe and Simvastatin Tablets
Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
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