Drug Enforcement D-0109-2024

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

Status

Terminated

Classification

Class II

Report Date

November 29, 2023

Termination Date

March 21, 2025

Product Information

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
Product quantity
1 55-gallon drum
Reason for recall
CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
Recall initiation reason
—
Initial firm notification
E-Mail
Distribution pattern
Distributed to one distributor in OK with possibility of further distribution

Location & Firm

Recalling firm
Integrity Bio-Chemicals LLC
Address
1100 N Cresson Hwy, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0109-2024
Event ID
93199
Recall initiation date
October 18, 2023
Center classification date
November 20, 2023
Code info
Lot #: 2133607, Manufacturing Date 11/23/2021 No Exp date on label.
More code info
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