FDA Drug Class II — Moderate

4-N-1 Skin Protectant, No Rinse Wash Cream with Dimethicone 1%, 113g, (4 oz) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-208-04

Hazard

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

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Products

4-N-1 Skin Protectant, No Rinse Wash Cream with Dimethicone 1%, 113g, (4 oz) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-208-04
Brand
DermaRite Industries, LLC
UPC
All lots on or before expiry date 08/2027.

Units Affected

3,178 bottles

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