FDA-Drug2023-11-29Class II

Integrity Biochem HSC70-LV, Alcohol Antiseptic 70%, Hand Sanitizer, Lavender Scented Topical Gel 208.19L (55 gallons) drum, Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the USA, NDC: 77512-047-03

Integrity Bio-Chemicals LLC
Hazard

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

Sold states
Distributed to one distributor in OK with possibility of further distribution
Affected count
1 55-gallon drum
Manufactured in
1100 N Cresson Hwy, N/A, Cresson, TX, United States
Products
Integrity Biochem HSC70-LV, Alcohol Antiseptic 70%, Hand Sanitizer, Lavender Scented Topical Gel 208.19L (55 gallons) drum, Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the USA, NDC: 77512-047-03

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0110-2024

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