Integrity Biochem HSC 70-LM — Class II drug recall D-0109-2024
Terminated recall by Integrity Bio-Chemicals LLC, reported 2023-11-29. CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP spe
| Recall number | D-0109-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integrity Bio-Chemicals LLC, Cresson, TX, United States |
| Recall initiated | 2023-10-18 |
| Classified | 2023-11-20 |
| Reported by FDA | 2023-11-29 |
| Terminated | 2025-03-21 |
| Reason classes | cgmp |
| NDC | 77512-0044-03 |
| Lot numbers | 2133607 |
Product
Integrity Biochem HSC 70-LM, Alcohol Antiseptic 70%, Hand Sanitizer, Lemon Scented Topical Gel, 208.19 L (55 gallons) drum, Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the USA NDC: 77512-044-03
Reason for recall
CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0109-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.