PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: November 29, 2023 Initiated: October 18, 2023 #D-0111-2024

Product Description

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.

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-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. 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-0111-2024.