Class II
Terminated
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC., Lenoir, NC 28645, NDC 51754-5001-1
- Company
- Exela Pharma Sciences Llc
- Recall Initiated
- January 11, 2022
- Posted
- January 19, 2022
- Recall Number
- D-0369-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 18,960 vials
- Firm Location
- Lenoir, NC, United States
Reason for Recall
Lack of Assurance of Sterility
Distribution
Nationwide within the United States
Lot / Code Info
Lot #: C0001088/P0001317, Exp. Date 08/2023
More recalls by Exela Pharma Sciences Llc
4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Si...
Sep 17, 2025 · Class II
8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per ca...
Apr 2, 2025 · Class II
ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single Dose Sterile...
Nov 29, 2023 · Class I
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