Integrity Biochem HSC70-LV, Alcohol Antiseptic 70%, Hand Sanitizer, Lavender Scented Topical Gel 208.19L (55 gallons) dr
Summary
The FDA issued a Class II for Integrity Biochem HSC70-LV, Alcohol Antiseptic 70%, Hand Sanitizer, Lavender Sce by Integrity Bio-Chemicals LLC. Reason: CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts..
Details
Source
Drug Recall
External ID
D-0110-2024
Action Date
2023-11-29
Status
Terminated
Category
drug
Product Description
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
Lot/Code Info: Lot #: 2133608, No exp Date. Manufacturing Date: 11/23/21
Quantity Affected: 1 55-gallon drum
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
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-18
Company
Cresson, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 38 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Integrity Bio-Chemicals LLC has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Integrity Bio-Chemicals LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Integrity Bio-Chemicals LLC have FDA actions?
Integrity Bio-Chemicals LLC has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0110-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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