FDA Drug Class II — Moderate

Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) per bottle, Manufactured for 2XL Corporation, 2 Gateway Ct, Ste A, Bolingbrook, IL 60440

Hazard

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

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Products

Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) per bottle, Manufactured for 2XL Corporation, 2 Gateway Ct, Ste A, Bolingbrook, IL 60440
UPC
Product Number 46101, Lots 722712-exp 07/22, 724755-exp 11/22, 725054-exp 12/22

Units Affected

4,632 cartons

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