FDAClass IIMarch 12, 2014

Lidocaine 4% Urethral Gel recall: Sterility Concern

Lidocaine 4% Urethral Gel

Why was Lidocaine 4% Urethral Gel recalled?

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 should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot# 101213, Exp. 04/14 Lot# 09202013, Exp. 03/14 Lot# 08272013, Exp. 02/14 Lot# 08022013, Exp. 01/14

Product
Lidocaine 4% Urethral Gel
Recalling firm
Natures Pharmacy & Compounding Center
Quantity
104 syringes
Distribution
NC
Recall date
March 12, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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