FDA-Drug2025-11-26Class II
Renew Skin Repair Cream, Dimethicone 1.5%, packaged in a) 5g tube (NDC 61924-405-05), b) 4 oz tube (NDC 61924-405-04), and c) 800 mL (NDC 61924-405-27), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
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
57,041 units
Manufactured in
7777 W Side Ave, North Bergen, NJ, United States
Products
Renew Skin Repair Cream, Dimethicone 1.5%, packaged in a) 5g tube (NDC 61924-405-05), b) 4 oz tube (NDC 61924-405-04), and c) 800 mL (NDC 61924-405-27), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0175-2026Don't want to check this manually?
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