July 2020 FDA Recall Drug by Spartan Chemical Co Inc
D-1503-2020 - Microbial contamination of non-sterile products

This Class I drug recall was voluntarily initiated by Spartan Chemical Co Inc on July 1, 2020 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile products. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1503-2020

Reason for Recall
Microbial contamination of non-sterile products: positive microbial contamination in product.
Initiated
07-01-2020
Reported
08-12-2020
Quantity
a) 60,796 cartridges, b) 420 gallon containers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85978
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA, Panama, St. Maarten
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.
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.

Batch or Lot Expiration Information

Lot# a) 42.27 oz cartridge: 518491, 518492, 518498, 518499, 518500, 520057, 520058, 520060, 520061; b) 1 gallon container: 520032, Exp. 06/30/2022.