FDA recall D-0111-2024

Integrity Bio-Chemicals LLC · Class II · drug

Product

Integrity Biochem HSC 70-VA, Alcohol Antiseptic 70%, Hand Sanitizer, Vanilla Scented Topical Gel 208.19L (55 gallons)- drum. Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the USA, NDC: 77512-052-03

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-0111-2024