FDAClass IIAugust 24, 2022

Stage 2-Ophardt Foaming Hand Sanitizer recall: CGMP Deviations

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…

Why was Stage 2-Ophardt Foaming Hand Sanitizer recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product Number 46101, Lots 722712-exp 07/22, 724755-exp 11/22, 725054-exp 12/22

Product
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…
Recalling firm
Aire-Master of America Inc
Quantity
4,632 cartons
Distribution
Florida, Illinois, Iowa, New Jersey
Recall date
August 24, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls