The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0361-2021·Announced 2021-04-21

Spartan Chemical Recalls Antiseptic Hand Cleaner Due to Manufacturing Deviations

Spartan Chemical Co Inc is recalling 400 gallons of Antiseptic Hand Cleaner 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when associated with manufacturing deviations that may affect product quality or safety.

Plain-English summary

Spartan Chemical Co Inc has voluntarily recalled 400 one-gallon containers of Antiseptic Hand Cleaner (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 identified by Lot 538885 with an expiration date of January 25, 2023. It is labeled for institutional and industrial use only. The product was distributed nationwide in the United States, Puerto Rico, and Mexico.

The recall was terminated on October 16, 2023. Consumers and institutions should check their inventory for this specific lot number and stop using the product if found.

The recalled product

Product
ANTISEPTIC HAND CLEANER (CHLOROXYLENOL)
Brand
ANTISEPTIC HAND CLEANER
Manufacturer
Spartan Chemical Co Inc
Category
Drug — OTC Drug
Hazard
Affected units
400

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 538885
  • exp 1/25/2023

UPCs (1)

  • 753727262571

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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