Recalls / Class II
Class IID-0360-2021
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
- Affected lot / code info
- Lot, expiry: Lot 526756, exp 9/22/2022; Lot 527499, exp 9/28/2022; Lot 527501, exp 9/30/2022
Why it was recalled
CGMP Deviations
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
- 26,328 cartridges
- 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-0360-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.