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Recall Observatory FDA recall evidence

Drug 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

D-0109-2024

October 18, 2023

Class II

Product summary

Firm
Integrity Bio-Chemicals LLC
Event
Event 93199
Status
Terminated
Classification
Class II
Quantity
1 55-gallon drum
Official record key
drug-enforcement:D-0109-2024

Official wording

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

Code information: Lot #: 2133607, Manufacturing Date 11/23/2021 No Exp date on label.

Distribution pattern: Distributed to one distributor in OK with possibility of further distribution

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviation