The Recall Desk
ModerateFDA (Drugs)·D-0667-2024·Announced 2024-10-02

Hand Sanitizer Manufacturer Recalls Product for Manufacturing Deviations

EnviroServe Chemicals Inc. is recalling EnviroClean Hand Sanitizer Gel due to manufacturing deviations. The voluntary recall affects 120 bottles distributed to one North Carolina distributor.

What this means for you

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: FDA Class II recalls with voluntary initiation and no reported illnesses or injuries are classified as Moderate per the severity rubric. The recall is for manufacturing process deviations (CGMP non-compliance) without known consumer harm.

Plain-English summary

EnviroServe Chemicals Inc. is recalling EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v) in 473 mL bottles due to manufacturing deviations that do not meet current good manufacturing practice (CGMP) standards. The voluntary recall was initiated on September 18, 2024, and classified as FDA Class II.

The recalled product is identified by lot number 042224-L1 with an expiration date of April 22, 2025 (NDC 76563-3010-1). A total of 120 bottles were distributed to one distributor in North Carolina. The manufacturer, EnviroServe Chemicals Inc., is located at 603 South Wilson Avenue, Dunn, NC 28334.

The recalled product

Product
EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v), 473 mL (16 fl. oz.) bottles, EnviroServe Chemicals Inc., 603 South Wilson Avenue, Dunn NC, 28334, NDC 76563-3010-1
Manufacturer
EnviroServe Chemicals Inc.
Category
Drug — Topical Antiseptic
Hazard
  • manufacturing-deviation

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 (2)

  • Lot #: 042224-L1
  • Exp. Date 04/22/2025

Distribution

Distribution scope not specified by the agency.

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