FDA Recall D-0022-2023

Exela Pharma Sciences LLC · Lenoir, NC

Class I — life-threatening Terminated 1102 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx only, Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645. Carton NDC 51754-5001-5, vial NDC 51754-5001-1

Lot / code: Lot # : P0001370, P0001371, P0001372, Exp. 10/2023; P0001433, P0001434 Exp. 11/2023; P0001443, P0001468, P0001469, P0001470, P0001495, P0001505, P0001506, P0001509, P0001510, P0001511, P0001512 Exp. 12/2023; P0001560, P0001561, P0001562, P0001564, P0001566, P0001567, P0001568 Exp. 01/2024; P0001571, P0001572, P0001573, P0001574, P0001578, P0001579, P0001580, P0001583, P0001586, P0001587, P0001588, P0001593, P0001594, P0001610, P0001618, P0001619, P0001654 Exp. 02/2024; P0001644, P0001645, P0001646, P0001662, P0001664 Exp. 03/2024; P0001730 Exp. 05/2024.

Quantity: 2,123,040 vials

Reason for recall

Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration

Recall record

Recall number: D-0022-2023
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide within the United States
Recall initiated: 2022-10-04
Classified by FDA Center: 2022-10-27
FDA published: 2022-11-02
Terminated: 2025-10-10
Recalling firm: Exela Pharma Sciences LLC
Firm location: Lenoir, NC

Drug identification

Brand name(s): SODIUM BICARBONATE
Generic name(s): SODIUM BICARBONATE
Manufacturer(s): Exela Pharma Sciences, LLC
NDC(s): 51754-5001, 51754-5011, 51754-5002, 51754-5012
Route(s): INTRAVENOUS

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