Drug product
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
D-0111-2024
Product summary
- Event
- Event 93199
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1-55 gallon drum
- Official record key
drug-enforcement:D-0111-2024
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 #: 2134106, No Exp date, Manufacturing Date: 11/23/21
Distribution pattern: Distributed to one distributor in OK with possibility of further distribution
Derived failure modes
-
Manufacturing or process control
CGMP Deviation