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
Product summary
- 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
CGMP Deviation