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Recall D-0111-2024

Description: 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

Recall D-0111-2024 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0111-2024
Event ID93199
DistributionDistributed to one distributor in OK with possibility of further distribution
Quantity1-55 gallon drum
Recall ReasonCGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
Drug ClassificationClass II
Drug Code Info20231129
Recall Initiation Date20231018
Report Date20231129
Classification Date20231120
Address1100 N Cresson Hwy
Cresson, TX 76035-4121
United States
Recalling FirmIntegrity Bio-Chemicals LLC
Initial Notification E-Mail
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