Key Takeaway

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 by Integrity Bio-Chemicals LLC was recalled on October 18, 2023. The hazard: CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.

FDA Drug 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

Recalled: October 18, 2023 ~1-55 gallon drum units affected D-0111-2024

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

Hazard / Reason

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

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

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

Drugs

Company Information

Integrity Bio-Chemicals LLC

Cresson, TX, United States

View all 3 recalls by Integrity Bio-Chemicals LLC →

Distribution

Distributed to one distributor in OK with possibility of further distribution

Related Recalls

Frequently Asked Questions

Is this recall still active?

Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

How do I check if my product is affected?

Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

This recall was issued by FDA Drug. Visit the agency's official website for the original notice.

Data sourced from FDA Drug Enforcement. Recall information may not reflect the most current status. RecallDex is not affiliated with any US government agency. Contact the manufacturer or relevant agency for the latest information.