FDA Recall D-0299-2022
Gilead Sciences, Inc. · Foster City, CA
Class I — life-threatening Terminated 234 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence 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
Reason for recall
Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates.
Recall record
- Recall number
D-0299-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide in the USA
- Recall initiated
- 2021-12-03
- Classified by FDA Center
- 2021-12-28
- FDA published
- 2022-01-05
- Terminated
- 2022-07-25
- Recalling firm
- Gilead Sciences, Inc.
- Firm location
- Foster City, CA
Drug identification
- Brand name(s)
- VEKLURY
- Generic name(s)
- REMDESIVIR
- Manufacturer(s)
- Gilead Sciences, Inc.
- NDC(s)
61958-2901, 61958-2902- Route(s)
- INTRAVENOUS