CLASS II Drug recall · Reported 29 Nov 2023 · FDA Enforcement Report
Integrity Biochem HSC 70-VA, Alcohol Antiseptic recalled
Integrity Bio-Chemicals is recalling Integrity Biochem HSC 70-VA, Alcohol Antiseptic 70%, Hand Sanitizer, Vanilla Scented. The recall was initiated on 18 Oct 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0111-2024
- FDA event ID
- 93199
- Recalling firm
- Integrity Bio-Chemicals, Cresson, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Oct 2023
- FDA classified
- 20 Nov 2023
- Reported
- 29 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Creams, Ointments & Gels
Timeline
| 18 Oct 2023 | Recall initiated by company | |
| 20 Nov 2023 | Classified by FDA | +33 days |
| 29 Nov 2023 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
Product as listed by the FDA
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
Where it was distributed
Distributed to one distributor in OK with possibility of further distribution
Questions about this recall
Is Integrity Biochem HSC 70-VA, Alcohol Antiseptic 70%, Hand Sanitizer, Vanilla Scented recalled?
Yes. Integrity Bio-Chemicals recalled Integrity Biochem HSC 70-VA, Alcohol Antiseptic 70%, Hand Sanitizer, Vanilla Scented on 18 Oct 2023. The recall is Class II and its status is Terminated. Recall number D-0111-2024.
Why was it recalled?
CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
Which lots are affected?
Lot #: 2134106, No Exp date, Manufacturing Date: 11/23/21
Where was it sold?
Distributed to one distributor in OK with possibility of further distribution
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Integrity Bio-Chemicals
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Integrity Biochem HSC70-LV, Alcohol Antiseptic recalled | Integrity Bio-Chemicals | Manufacturing (CGMP) Deviations | TX |
| Drug | CLASS II | Integrity Biochem HSC 70-LM, Alcohol Antiseptic recalled | Integrity Bio-Chemicals | Manufacturing (CGMP) Deviations | TX |