FDA-Drug2025-11-26Class II

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

DermaRite Industries, LLC
Hazard

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

Sold states
Nationwide in the USA
Affected count
37,272 tubes
Manufactured in
7777 W Side Ave, North Bergen, NJ, United States
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0174-2026

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