Nephron Sterile Compounding Center LLC: Drug Recall

Recall #D-1279-2022 · 06/30/2022

Class II: Risk

Recall Details

Recall Number: D-1279-2022
Classification: Class II
Product Type: Drug
Recalling Firm: Nephron Sterile Compounding Center LLC
Status: Terminated
Date Initiated: 06/30/2022
Location: West Columbia, SC, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 36,354 syringes

Reason for Recall

Lack of Assurance of Sterility

Product Description

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

Distribution Pattern

Nationwide in the USA

Other Recalls by Nephron Sterile Compounding Center LLC

Class II: Risk 02/10/2025

Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
Class II: Risk 02/22/2023

Lack of Assurance of Sterility
Class II: Risk 02/22/2023

Lack of Assurance of Sterility
Class II: Risk 02/22/2023

Lack of Assurance of Sterility
Class II: Risk 02/22/2023

Lack of Assurance of Sterility

View all recalls by Nephron Sterile Compounding Center LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.