FDA-Drug2025-11-26Class II

GelRite Instant Hand Sanitizer, Alcohol 65%, packaged in a) 118 mL (NDC 61924-106-04), b) 473 mL (NDC 61924-106-16) and c) 800 mL (NDC 61924-106-27), and d) 1000 mL (NDC 61924-106-34) per container, 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
115,994 containers
Manufactured in
7777 W Side Ave, North Bergen, NJ, United States
Products
GelRite Instant Hand Sanitizer, Alcohol 65%, packaged in a) 118 mL (NDC 61924-106-04), b) 473 mL (NDC 61924-106-16) and c) 800 mL (NDC 61924-106-27), and d) 1000 mL (NDC 61924-106-34) per container, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0166-2026

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