FDA-Drug2025-11-26Class IIPROCESSING DEFECT
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.
Hazard
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Who it affects
All ages
Illnesses reported
None reported
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-0166-2026Don't want to check this manually?
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