Nephron Sterile Compounding Center LLC: Drug Recall

Recall #D-0361-2023 · 02/22/2023

Class II: Risk

Recall Details

Recall Number: D-0361-2023
Classification: Class II
Product Type: Drug
Recalling Firm: Nephron Sterile Compounding Center LLC
Status: Terminated
Date Initiated: 02/22/2023
Location: West Columbia, SC, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 24,870 vials

Reason for Recall

Lack of Assurance of Sterility

Product Description

Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-301-10.

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.