FDA recall D-1357-2022

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, Bolingbrook, IL 60440

Reason for recall

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

Distribution

Florida, Illinois, Iowa, New Jersey

Key facts

Status

Terminated

Initiation date

2022-07-15

Report date

2022-08-24

Termination date

2023-02-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Nixa, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1357-2022