FDA Recall D-0303-2025

Exela Pharma Sciences LLC · Lenoir, NC

Class II Ongoing 433 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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

Lot / code: Lots: 10006417 and 10006418, Exp. 11/30/2026

Quantity: 103,950 vials

Reason for recall

Lack of Assurance of Sterility

Recall record

Recall number: D-0303-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide
Recall initiated: 2025-03-07
Classified by FDA Center: 2025-03-27
FDA published: 2025-04-02
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

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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