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Recall Observatory FDA recall evidence

Drug product

SHEER DesenZ Desensitizing Treatment, Rx Only, Potassium Nitrate 12mg per film. CAO GROUP, INC, 4628 West Skyhawk Drive West Jordan, UT 84084. UPC: 8 72320 00072 1 NDC 1406000304

D-0291-2019

November 16, 2018

Class II

Product summary

Firm
CAO Group, Inc.
Event
Event 81556
Status
Terminated
Classification
Class II
Quantity
71 cartons
Official record key
drug-enforcement:D-0291-2019

Official wording

Reason: cGMP violations noted during the firm's most recent inspection.

Code information: Lot # 170626, EXP 6/26/2019; and 180131, EXP 01/31/2020

Distribution pattern: Nationwide in the US

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP violations