D-0233-2024 Class I Ongoing
FDA drug recall D-0233-2024 was initiated by Pfizer Inc. on December 21, 2023 and is designated Class I. Reason for recall: Presence of Particulate Matter; identified as glass The recall status is ongoing. Affected quantity: 34000 Cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- January 24, 2024
- Initiation Date
- December 21, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 34000 Cartons
Product Description
4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJECT Unit of Use Syringe, For Intravenous Use, Rx Only, 10 mL Syringe per Carton, Hospira, Inc., Lake Forst, IL 60045, NDC 0409-5534-24 (carton), 0409-5534-14 (case).
Reason for Recall
Presence of Particulate Matter; identified as glass
Distribution Pattern
Nationwide in the USA and Puerto Rico.
Code Information
Lot GX1542, Exp. 01/01/2025