FDA recall D-0109-2024

Product

Integrity Biochem HSC 70-LM, Alcohol Antiseptic 70%, Hand Sanitizer, Lemon Scented Topical Gel, 208.19 L (55 gallons) drum, Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the USA NDC: 77512-044-03

Reason for recall

CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.

Distribution

Distributed to one distributor in OK with possibility of further distribution

Key facts

Status

Terminated

Initiation date

2023-10-18

Report date

2023-11-29

Termination date

2025-03-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cresson, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0109-2024