Multi-event March 2021 FDA Recall Lite Nfoamy Eucalyptus Mint Sanitizing Handwash by Spartan Chemical Co Inc

This Multi-event Class II drug recall was voluntarily initiated by Spartan Chemical Co Inc on March 29, 2021 for the product Lite Nfoamy Eucalyptus Mint Sanitizing Handwash. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0364-2021 TERMINATED D-0359-2021 TERMINATED D-0360-2021 TERMINATED D-0362-2021 TERMINATED D-0361-2021 TERMINATED D-0363-2021 TERMINATED

Recall Number: D-0364-2021

Reason for Recall
CGMP Deviations
Initiated
03-29-2021
Reported
04-21-2021
Quantity
960 containers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87633
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Spartan Chemical Co Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA and Puerto Rico; Mexico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-16-2023
Product Description About Product Description
Full technical description of the product.
Lite'n Foamy Healthcare Personnel Handwash (Chloroxylenol, 1.0%), 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 26283 0 NDC: 64009-335-82

Batch or Lot Expiration Information

Lot# Lot, expiry: Lot 538310, exp 1/21/2023

Affected Packages Involved in this Recall

64009-335-85 Lite Nfoamy Healthcare Personnel Handwash
64009-335-82 Lite Nfoamy Healthcare Personnel Handwash

Recall Number: D-0359-2021

Reason for Recall
Microbial Contamination of Non-Sterile Products; lot tested positive for Bulkholderia multivorans
Initiated
03-29-2021
Reported
04-21-2021
Quantity
19,044 containers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87633
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Spartan Chemical Co Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA and Puerto Rico; Mexico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-16-2023
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lot 538305, exp 1/14/2023

Recall Number: D-0360-2021

Reason for Recall
CGMP Deviations
Initiated
03-29-2021
Reported
04-21-2021
Quantity
26,328 cartridges

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87633
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Spartan Chemical Co Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA and Puerto Rico; Mexico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-16-2023
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lot, expiry: Lot 526756, exp 9/22/2022; Lot 527499, exp 9/28/2022; Lot 527501, exp 9/30/2022

Recall Number: D-0362-2021

Reason for Recall
CGMP Deviations
Initiated
03-29-2021
Reported
04-21-2021
Quantity
2,152 containers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87633
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Spartan Chemical Co Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA and Puerto Rico; Mexico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-16-2023
Product Description About Product Description
Full technical description of the product.
Lite'n Foamy E2 Sanitizing Handwash (Benzalkonium Chloride, 0.13%), Net Contents: 1 US Gallon/ 3.79 Liters per gallon container, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA. UPC 7 53727 26116 1 NDC: 64009-333-95

Batch or Lot Expiration Information

Lot# Lot, expiry: Lot 538882, exp 1/22/2023

Affected Packages Involved in this Recall

64009-333-95 Lite Nfoamy E2 Sanitizing Handwash
64009-333-98 Lite Nfoamy E2 Sanitizing Handwash

Recall Number: D-0361-2021

Reason for Recall
CGMP Deviations
Initiated
03-29-2021
Reported
04-21-2021
Quantity
400 containers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87633
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Spartan Chemical Co Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA and Puerto Rico; Mexico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-16-2023
Product Description About Product Description
Full technical description of the product.
Antiseptic Hand Cleaner (Chloroxylenol, 1.0%), Net Contents: 1 US Gallon/ 3.79 Liters per gallon container, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA.UPC 7 53727 26257 1 NDC: 64009-336-85

Batch or Lot Expiration Information

Lot# Lot, expiry: Lot 538885, exp 1/25/2023

Affected Packages Involved in this Recall

64009-336-85 Antiseptic Hand Cleaner
64009-336-90 Antiseptic Hand Cleaner
64009-336-91 Antiseptic Hand Cleaner

Recall Number: D-0363-2021

Reason for Recall
CGMP Deviations
Initiated
03-29-2021
Reported
04-21-2021
Quantity
1,200 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87633
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Spartan Chemical Co Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA and Puerto Rico; Mexico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-16-2023
Product Description About Product Description
Full technical description of the product.
Lite'n Foamy Eucalyptus Mint Sanitizing Handwash (Benzalkonium Chloride, 0.13%), 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 53525 26287 8 NDC: 64009-332-72

Batch or Lot Expiration Information

Lot# Lot, expiry: Lot 538307, exp 1/20/2023

Affected Packages Involved in this Recall

64009-332-75 Lite Nfoamy Eucalyptus Mint Sanitizing Handwash
64009-332-78 Lite Nfoamy Eucalyptus Mint Sanitizing Handwash
64009-332-72 Lite Nfoamy Eucalyptus Mint Sanitizing Handwash