The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0364-2021·Announced 2021-04-21

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

Spartan Chemical Co Inc is voluntarily recalling 960 containers of Lite'n Foamy Healthcare Personnel Handwash due to CGMP deviations. The product was distributed nationwide in the US, Puerto Rico, and Mexico.

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 and is voluntary, initiated by the firm due to CGMP deviations without reported illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Spartan Chemical Co Inc has voluntarily recalled 960 containers of Lite'n Foamy Healthcare Personnel Handwash (Chloroxylenol, 1.0%). The recall was initiated on March 29, 2021, and was classified as Class II by the FDA. The reason for the recall is cited as Current Good Manufacturing Practice (CGMP) deviations.

The affected product is an 18 oz/532 ml foam pump container intended for institutional and industrial use only. The specific lot number is 538310, with an expiration date of January 21, 2023. The product was distributed nationwide in the United States, Puerto Rico, and Mexico.

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

The recalled product

Product
LITE NFOAMY HEALTHCARE PERSONNEL HANDWASH (CHLOROXYLENOL)
Brand
LITE NFOAMY HEALTHCARE PERSONNEL HANDWASH
Manufacturer
Spartan Chemical Co Inc
Category
Drug — OTC Drug
Hazard
Affected units
960

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 538310
  • exp 1/21/2023

UPCs (1)

  • 753727262830

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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