Drug product
Lite'n Foamy E2 Sanitizing Handwash (Benzalkonium Chloride, 0.13%), Net Contents: 1 US Gallon/ 3.79 Liters per gallon container, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA. UPC 7 53727 26116 1 NDC: 64009-333-95
D-0362-2021
Product summary
- Event
- Event 87633
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,152 containers
- Official record key
drug-enforcement:D-0362-2021
Official wording
Reason: CGMP Deviations
Code information: Lot, expiry: Lot 538882, exp 1/22/2023
Distribution pattern: Nationwide USA and Puerto Rico; Mexico
Derived failure modes
-
Manufacturing or process control
CGMP Deviations