FDA Drug Class II — Moderate

Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per carton, Manufactured for Protect U Guard, Tampa 33606.

Hazard

CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.

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Products

Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per carton, Manufactured for Protect U Guard, Tampa 33606.
UPC
Product Number 46112, Lots 722782 -exp 08/22

Units Affected

960 cartons

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