PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: November 29, 2023 Initiated: October 18, 2023 #D-0109-2024

Product Description

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.

Details

Units Affected
1 55-gallon drum
Distribution
Distributed to one distributor in OK with possibility of further distribution
Location
Cresson, TX

Frequently Asked Questions

What product was recalled?
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. Recalled by Integrity Bio-Chemicals LLC. Units affected: 1 55-gallon drum.
Why was this product recalled?
CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 29, 2023. Severity: Moderate. Recall number: D-0109-2024.