Home / Recalls / Gentell, Inc / D-0866-2017

D-0866-2017 Class II Terminated

Recalled by Gentell, Inc — Bristol, PA

Recall Details

Product Type
Drugs
Report Date
May 31, 2017
Initiation Date
April 19, 2017
Termination Date
February 16, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
65 gallons

Product Description

Shield and Protect Moisture Barrier Cream, 1.1% Clotrimazole, Net Weight 4 oz - 115 g Anti-Fungal, Gentell, Inc., Bristol, PA NDC 61554-232-40

Reason for Recall

GMP Deviations; product may not meet cGMP requirements

Distribution Pattern

Nationwide and Puerto Rico

Code Information

Product Code GEN-23240

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