Recalls / Class I
Class ID-0359-2021
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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
- Affected lot / code info
- Lot 538305, exp 1/14/2023
Why it was recalled
Microbial Contamination of Non-Sterile Products; lot tested positive for Bulkholderia multivorans
Recalling firm
- Firm
- Spartan Chemical Co Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1110 Spartan Dr, N/A, Maumee, Ohio 43537-1725
Distribution
- Quantity
- 19,044 containers
- Distribution pattern
- Nationwide USA and Puerto Rico; Mexico
Timeline
- Recall initiated
- 2021-03-29
- FDA classified
- 2021-04-30
- Posted by FDA
- 2021-04-21
- Terminated
- 2023-10-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0359-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.