Status
Terminated
Drug Enforcement D-0184-2023
Presence of Particulate Matter: Glass particulate matter detected in injectable.
Classification
Class I
Report Date
February 1, 2023
Termination Date
August 7, 2024
Product Information
- Product description
- 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
- Product quantity
- 89,700 vials
- Reason for recall
- Presence of Particulate Matter: Glass particulate matter detected in injectable.
- Recall initiation reason
- —
- Initial firm notification
- Press Release
- Distribution pattern
- USA nationwide and Puerto Rico
Location & Firm
- Recalling firm
- Pfizer Inc.
- Address
-
235 East 42nd Street, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0184-2023
- Event ID
- 91346
- Recall initiation date
- December 22, 2022
- Center classification date
- January 25, 2023
- Code info
- Lot: 33045BA, EXP 1SEP2023
- More code info
- —