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Recall Observatory FDA recall evidence

Drug product

Lidocaine 4% Urethral Gel

D-1098-2014

November 01, 2013

Class II

Product summary

Firm
Natures Pharmacy & Compounding Center
Event
Event 66856
Status
Terminated
Classification
Class II
Quantity
104 syringes
Official record key
drug-enforcement:D-1098-2014

Official wording

Reason: 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.

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

Distribution pattern: NC

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Sterility