FDA Recall D-0079-2023

Exela Pharma Sciences LLC · Lenoir, NC

Class I — life-threatening Terminated 1047 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: Lots: P0001178 Exp. 05/2023; P0001298, P0001301, P0001313, P0001314, P0001317 Exp. 08/2023; P0001330, P0001464 Exp. 09/2023; P0001442 Exp. 11/2023; P0001467, P0001472, P0001486, P0001532 Exp. 12/2023.

Quantity: 489,600 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-0079-2023
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Nationwide within the United States
Recall initiated: 2022-11-28
Classified by FDA Center: 2022-12-13
FDA published: 2022-12-21
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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