FDA Recall D-0184-2023
Pfizer Inc. · New York, NY
Class I — life-threatening Terminated 594 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Vancomycin Hydrochloride for Injection, USP, 1.5 g/vial, Sterile powder, Single-dose Fliptop Vial, 10 vials per carton, Rx only, Distributed by: Hospira, Inc., Lake Forest, IL 60045. NDC Vial 0409-3515-11; NDC Carton 0409-3515-01
Reason for recall
Presence of Particulate Matter: Glass particulate matter detected in injectable.
Recall record
- Recall number
D-0184-2023- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- USA nationwide and Puerto Rico
- Recall initiated
- 2022-12-22
- Classified by FDA Center
- 2023-01-25
- FDA published
- 2023-02-01
- Terminated
- 2024-08-07
- Recalling firm
- Pfizer Inc.
- Firm location
- New York, NY
Drug identification
- Brand name(s)
- VANCOMYCIN HYDROCHLORIDE
- Generic name(s)
- VANCOMYCIN HYDROCHLORIDE
- Manufacturer(s)
- Hospira, Inc.
- NDC(s)
0409-3515, 0409-6531, 0409-6533, 0409-4332- Route(s)
- INTRAVENOUS