Nephron Sterile Compounding Center LLC: Drug Recall

Recall #D-1347-2022 · 08/10/2022

Class II: Risk

Recall Details

Recall Number: D-1347-2022
Classification: Class II
Product Type: Drug
Recalling Firm: Nephron Sterile Compounding Center LLC
Status: Terminated
Date Initiated: 08/10/2022
Location: West Columbia, SC, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 33,870 vials

Reason for Recall

CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.

Product Description

PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-946-34

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.