The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0362-2021·Announced 2021-04-21

Spartan Chemical Recalls Lite'n Foamy E2 Sanitizing Handwash Due to CGMP Deviations

Spartan Chemical Co Inc is voluntarily recalling 2,152 containers of Lite'n Foamy E2 Sanitizing Handwash due to Current Good Manufacturing Practice (CGMP) deviations.

The agency’s classification

FDA (Drugs): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II due to CGMP deviations, which typically represents a theoretical risk of harm or minor labeling errors without reported injuries, fitting the Moderate severity criteria.

Plain-English summary

Spartan Chemical Co Inc is voluntarily recalling 2,152 containers of Lite'n Foamy E2 Sanitizing Handwash (Benzalkonium Chloride, 0.13%). The product is sold in 1 US gallon containers and is intended for institutional and industrial use only. The recall was initiated on March 29, 2021, and was classified as Class II by the FDA.

The reason for the recall is Current Good Manufacturing Practice (CGMP) deviations. The affected product is identified by Lot 538882 with an expiration date of 1/22/2023. The product was distributed nationwide in the United States, Puerto Rico, and Mexico.

Consumers and institutions should stop using the affected product and contact Spartan Chemical Co Inc for further instructions. The recall status is currently terminated.

The recalled product

Product
LITE NFOAMY E2 SANITIZING HANDWASH (BENZALKONIUM CHLORIDE)
Brand
LITE NFOAMY E2 SANITIZING HANDWASH
Manufacturer
Spartan Chemical Co Inc
Category
Drug — OTC Drug
Hazard
Affected units
2,152

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lot
  • expiry: Lot 538882
  • exp 1/22/2023

UPCs (2)

  • 0753727261161
  • 753727261161

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 6 recalled by Spartan Chemical Co Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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