Recalls / Class I
Class ID-0299-2022
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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
- Brand name
- Veklury
- Generic name
- Remdesivir
- Active ingredient
- Remdesivir
- Route
- Intravenous
- NDCs
- 61958-2901, 61958-2902
- FDA application
- NDA214787
- Affected lot / code info
- Lots: 2141001-1A, 2141002-1A, Exp. 01/2024
Why it was recalled
Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates.
Recalling firm
- Firm
- Gilead Sciences, Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 333 Lakeside Dr, Foster City, California 94404-1147
Distribution
- Quantity
- 53,473 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2021-12-03
- FDA classified
- 2021-12-28
- Posted by FDA
- 2022-01-05
- Terminated
- 2022-07-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0299-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.