Fagron Compounding Services: Drug Recall

Recall #D-0636-2024 · 08/15/2024

Class II: Risk

Recall Details

Recall Number: D-0636-2024
Classification: Class II
Product Type: Drug
Recalling Firm: Fagron Compounding Services
Status: Ongoing
Date Initiated: 08/15/2024
Location: Wichita, KS, United States
Voluntary/Mandated: Voluntary: Firm initiated

Reason for Recall

Lack of Assurance of Sterility

Product Description

Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) per syringe, Rx only, Fagron Sterile Services, 8710 E. 34th St, N. Wichita, KS 57226.

Distribution Pattern

Nationwide in the USA

Other Recalls by Fagron Compounding Services

Class II: Risk 11/20/2025

Incorrect Product Formulation
Class II: Risk 08/29/2025

Lack of Assurance of Sterility
Class II: Risk 01/31/2025

Lack of Assurance of Sterility
Class III: Low Risk 11/10/2023

Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use syringe instead of a 5 mL dropper

View all recalls by Fagron Compounding Services →

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.