Class II
Ongoing
8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenous Use Only, Rx Only, Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 28645. NDC Inner Vial: 51754-5001-1; NDC Carton: 51754-5001-4
This recall is currently active, issued April 2, 2025. It was issued by Exela Pharma Sciences Llc.
- Company
- Exela Pharma Sciences Llc
- Recall Initiated
- March 7, 2025
- Posted
- April 2, 2025
- Recall Number
- D-0303-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 103,950 vials
- Firm Location
- Lenoir, NC, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of Assurance of Sterility
Distribution
Nationwide
Lot / Code Info
Lots: 10006417 and 10006418, Exp. 11/30/2026
More recalls by Exela Pharma Sciences Llc
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Nov 29, 2023 · Class I
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in...
Dec 21, 2022 · Class I
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