Why it was recalled
Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates.
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 numbers, UPCs & expiration codes
Lots: 2141001-1A, 2141002-1A, Exp. 01/2024
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0299-2022
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 3, 2021
- FDA report date
- Jan 5, 2022
- Quantity
- 53,473 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Gilead Sciences, Inc.
Original FDA data
Every field from FDA enforcement report D-0299-2022, exactly as published.
Show all FDA fields
- City
- Foster City
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 89153
- Address
- 333 Lakeside Dr
- Code information
- Lots: 2141001-1A, 2141002-1A, Exp. 01/2024
- Postal code
- 94404-1147
- Report date
- Jan 5, 2022
- Product type
- Drugs
- Recall number
- D-0299-2022
- Classification
- Class I
- Recalling firm
- Gilead Sciences, Inc.
- Product quantity
- 53,473 vials
- Termination date
- Jul 25, 2022
- Reason for recall
- Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Dec 3, 2021
- Initial firm notification
- Press Release
- Center classification date
- Dec 28, 2021