FDA Drug Class II — Moderate

Renew PeriProtect, Zinc Oxide 12%, Dimethicone 1%, 113g (4 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-435-04

Hazard

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

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Products

Renew PeriProtect, Zinc Oxide 12%, Dimethicone 1%, 113g (4 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-435-04
Brand
DermaRite Industries, LLC
UPC
All lots on or before expiry date 08/2027

Units Affected

37,272 tubes

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