D-0109-2024Class II

Integrity Bio-Chemicals LLC

Recalling firm

Product type

Drug

Status

Terminated

Report date

2023-11-29

Distribution

Distributed to one distributor in OK with possibility of further distribution

Firm state

Product quantity

1 55-gallon drum

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Risk Management & CAPA

Reason for recall

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

Product description

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

Code / lot info

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

Other recalls SPEQ maps to Risk Management & CAPA

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See all Risk Management & CAPA recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.