Recalls / Class I
Class ID-1503-2020
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
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.
- Affected lot / code info
- a) 42.27 oz cartridge: 518491, 518492, 518498, 518499, 518500, 520057, 520058, 520060, 520061; b) 1 gallon container: 520032, Exp. 06/30/2022.
Why it was recalled
Microbial contamination of non-sterile products: positive microbial contamination in product.
Recalling firm
- Firm
- Spartan Chemical Co Inc
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 1110 Spartan Dr, Maumee, Ohio 43537-1725
Distribution
- Quantity
- a) 60,796 cartridges, b) 420 gallon containers
- Distribution pattern
- Nationwide USA, Panama, St. Maarten
Timeline
- Recall initiated
- 2020-07-01
- FDA classified
- 2020-08-14
- Posted by FDA
- 2020-08-12
- Terminated
- 2023-10-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1503-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.