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D-0369-2022 Class II Terminated

Recalled by Exela Pharma Sciences LLC — Lenoir, NC

FDA drug recall D-0369-2022 was initiated by Exela Pharma Sciences LLC on Jan 11, 2022 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated Dec 2, 2022). Affected quantity: 18,960 vials.

Recall Details

Product Type: Drugs
Report Date: Jan 19, 2022
Initiation Date: Jan 11, 2022
Termination Date: Dec 2, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 18,960 vials

Product Description

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

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: C0001088/P0001317, Exp. Date 08/2023

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0369-2022
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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D-1585-2020 Class III — Potassium Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) Single Dose Vials, Rx… (May 5, 2020)