FDAFDA · Food and drugs·Recall number D-1098-2014
Lidocaine 4% Urethral Gel
Published March 12, 2014 · Recall initiated: November 1, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Natures Pharmacy & Compounding Center
- Distributor
- NC
- Lot
- Lot# 101213, Exp. 04/14 Lot# 09202013, Exp. 03/14 Lot# 08272013, Exp. 02/14 Lot# 08022013, Exp. 01/14
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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