Integrity Biochem recalls 55-gallon hand sanitizer due to third-party tests finding acetal and acetaldehyde above USP limits. Consumers should check product labels for NDC 77512-052-03 and lot 2134106.
CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
Integrity Biochem is recalling 55-gallon vanilla-scented hand sanitizer because third-party tests found acetal and acetaldehyde at levels above USP standards. This could pose a risk of skin irritation or other health effects if used improperly.
The hand sanitizer contains acetal and acetaldehyde at levels exceeding USP specifications. These chemicals can cause skin irritation or allergic reactions in some users, especially those with sensitive skin.
Anyone who owns or uses the recalled 55-gallon hand sanitizer with NDC 77512-052-03 and lot number 2134106. People with sensitive skin may be at higher risk of irritation.
Check for the product name: 'Integrity Biochem HSC 70-VA, Alcohol Antiseptic 70%, Hand Sanitizer, Vanilla Scented Topical Gel 208.19L (55 gallons)'. Look for NDC code 77512-052-03 and lot number 2134106 on the label.
Look for NDC code 77512-052-03 and lot number 2134106 on the product label.
The recall is due to third-party tests finding acetal and acetaldehyde above USP limits, which may cause skin irritation. Use only if you check the label for the specific NDC and lot number.
Check for the product name 'Integrity Biochem HSC 70-VA, Alcohol Antiseptic 70%, Hand Sanitizer, Vanilla Scented Topical Gel 208.19L (55 gallons)' with NDC 77512-052-03 and lot number 2134106.
The recall does not specify a remedy, so check the label for the NDC and lot number to confirm. Contact Integrity Biochem at 1100 North Cresson Hwy, Cresson, TX 76035 for further assistance.
We’ve drafted a message you can send Integrity Bio-Chemicals to request your refund or repair — edit it as you like.
Subject: Recall D-0111-2024 — Integrity Bio-Chemicals Integrity Bio-Chemicals Hello, I own a Integrity Bio-Chemicals that is covered by recall D-0111-2024 from Integrity Bio-Chemicals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
