Drug product
MAXIM Assure Antibacterial, Chloroxylenol 0.1%, Net Contents: One U.S. Gallon (3.78 L), For Industrial and Institutional Use Only, MIDLAB 140 Private Brand Way, Athens, TN 37303
D-0087-2025
Product summary
- Event
- Event 95826
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0087-2025
Official wording
Reason: cGMP Deviations: Out of specification results for micro in hand soap products.
Code information: Lot 0711241
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
cGMP Deviations
-
Potency or specification failure
Out of specification