← FDA ENFORCEMENT
D-0303-2025Class II

Exela Pharma Sciences LLC

Recalling firm
Exela Pharma Sciences LLC
Product type
Drug
Status
Ongoing
Report date
2025-04-02
Distribution
Nationwide
Firm state
NC
Product quantity
103,950 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of Assurance of Sterility

Product description

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

Code / lot info

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

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.