Lidocaine 4% Urethral Gel
FDA Recall #D-1098-2014 — Class II — November 1, 2013
Product Description
Lidocaine 4% Urethral Gel
Reason for Recall
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recalling Firm
Natures Pharmacy & Compounding Center — Asheville, NC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
104 syringes
Distribution
NC
Code Information
Lot# 101213, Exp. 04/14 Lot# 09202013, Exp. 03/14 Lot# 08272013, Exp. 02/14 Lot# 08022013, Exp. 01/14
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated