Drug 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
D-0184-2023
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 91346
- Status
- Terminated
- Classification
- Class I
- Quantity
- 89,700 vials
- Official record key
drug-enforcement:D-0184-2023
Official wording
Reason: Presence of Particulate Matter: Glass particulate matter detected in injectable.
Code information: Lot: 33045BA, EXP 1SEP2023
Distribution pattern: USA nationwide and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter