Drug product
Maxim Instant Foam Hand Sanitizer (benzalkonium chloride 0.1%) packaged in a) 1 U.S. Gallon (3.78 Liters) drums UPC 7 61841 02502 6 and b) 55 U.S. Gallon drums (208 Liters) UPC 0 07 61841 02504 0, Midlab 140 Private Brand Way, Athens, TN 37303
D-1463-2022
Product summary
- Event
- Event 90756
- Status
- Terminated
- Classification
- Class II
- Quantity
- 892 gallons and one 55-gallon drum
- Official record key
drug-enforcement:D-1463-2022
Official wording
Reason: CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride.
Code information: Lot #: a) 03292022-1, 05092022-1, 02012022-1, 06172022-1, 12132021-1, 07272022-1, and b) 06252022-1
Distribution pattern: Naionwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations