Drug product
Lite'n Foamy Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1%), Net Contents: 18 oz/ 532 ml per foam pump container, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA. UPC 7 53727 26288 5 SKU# 333806 NDC: 64009-331-82
D-0359-2021
Product summary
- Event
- Event 87633
- Status
- Terminated
- Classification
- Class I
- Quantity
- 19,044 containers
- Official record key
drug-enforcement:D-0359-2021
Official wording
Reason: Microbial Contamination of Non-Sterile Products; lot tested positive for Bulkholderia multivorans
Code information: Lot 538305, exp 1/14/2023
Distribution pattern: Nationwide USA and Puerto Rico; Mexico
Derived failure modes
-
Microbial contamination
Microbial Contamination