Drug product
foamyiQ Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1%), Net Contents: 42.27 oz/1250 ml per foam pump cartridge, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA. UPC 7 53727 26454 4 NDC: 64009-202-06
D-0360-2021
Product summary
- Event
- Event 87633
- Status
- Terminated
- Classification
- Class II
- Quantity
- 26,328 cartridges
- Official record key
drug-enforcement:D-0360-2021
Official wording
Reason: CGMP Deviations
Code information: Lot, expiry: Lot 526756, exp 9/22/2022; Lot 527499, exp 9/28/2022; Lot 527501, exp 9/30/2022
Distribution pattern: Nationwide USA and Puerto Rico; Mexico
Derived failure modes
-
Manufacturing or process control
CGMP Deviations