Home / Recalls / Nephron Sterile Compounding Center LLC / D-0950-2022

D-0950-2022 Class II Terminated

Recalled by Nephron Sterile Compounding Center LLC — West Columbia, SC

FDA drug recall D-0950-2022 was initiated by Nephron Sterile Compounding Center LLC on May 18, 2022 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated Aug 23, 2024). Affected quantity: 13612 syringes.

Recall Details

Product Type: Drugs
Report Date: Jun 8, 2022
Initiation Date: May 18, 2022
Termination Date: Aug 23, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 13612 syringes

Product Description

8.4% Sodium Bicarbonate Injection, USP, 1 mEq/mL, 4.2 g/50 mL (84 mg/mL), 1 x 50 mL Pre-Filled Syringe, packaged in a) 10 x 1 syringe carton, b) 30 x 1 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-214-50

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide in the USA

Code Information

Lots: SB2001A, Exp. 1/2/2023; SB2005B, SB2005C, Exp. 3/8/2023; SB2006A, SB2006B, SB2006C, Exp. 3/16/2023

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0950-2022
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 26, 2026

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

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