FDA Recall D-0359-2021
Spartan Chemical Co Inc · Maumee, OH
Class I — life-threatening Terminated 931 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
Reason for recall
Microbial Contamination of Non-Sterile Products; lot tested positive for Bulkholderia multivorans
Recall record
- Recall number
D-0359-2021- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide USA and Puerto Rico; Mexico
- Recall initiated
- 2021-03-29
- Classified by FDA Center
- 2021-04-30
- FDA published
- 2021-04-21
- Terminated
- 2023-10-16
- Recalling firm
- Spartan Chemical Co Inc
- Firm location
- Maumee, OH