Drug product
Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1% - antimicrobial), For Institutional and Industrial Use Only, a) foamyiQ 42.27 oz/1250 mL cartridge, UPC code: 7 53727 26454 4; b) Lite 'n Foamy 1 gallon/3.79 L container UPC code: 7 53727 26113 0, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA.
D-1503-2020
Product summary
- Event
- Event 85978
- Status
- Terminated
- Classification
- Class I
- Quantity
- a) 60,796 cartridges, b) 420 gallon containers
- Official record key
drug-enforcement:D-1503-2020
Official wording
Reason: Microbial contamination of non-sterile products: positive microbial contamination in product.
Code information: a) 42.27 oz cartridge: 518491, 518492, 518498, 518499, 518500, 520057, 520058, 520060, 520061; b) 1 gallon container: 520032, Exp. 06/30/2022.
Distribution pattern: Nationwide USA, Panama, St. Maarten
Derived failure modes
-
Microbial contamination
Microbial contamination