FDAClass IINovember 29, 2023

Integrity Biochem HSC 70-VA recall: CGMP Deviations

Integrity Biochem HSC 70-VA, Alcohol Antiseptic 70%, Hand Sanitizer, Vanilla Scented Topical Gel 208.19L (55 gallons)- drum. Integrity Biochem, 1100…

Why was Integrity Biochem HSC 70-VA recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 2134106, No Exp date, Manufacturing Date: 11/23/21

Product
Integrity Biochem HSC 70-VA, Alcohol Antiseptic 70%, Hand Sanitizer, Vanilla Scented Topical Gel 208.19L (55 gallons)- drum. Integrity Biochem, 1100…
Recalling firm
Integrity Bio-Chemicals LLC
Quantity
1-55 gallon drum
Distribution
Distributed to one distributor in OK with possibility of further distribution
Recall date
November 29, 2023
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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