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Drug FDA Class II Ongoing cGMP deviation

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

EnviroServe Chemicals Inc. Published Oct 2, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 50/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact EnviroServe Chemicals Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

CGMP deviations

Affected products (1)

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

120 bottles

Code info: Lot #: 042224-L1, Exp. Date 04/22/2025

Affected areas

North Carolina

Timeline

  1. Initiated
    Sep 18, 2024
  2. Published
    Oct 2, 2024
Recall number
D-0667-2024
Agency
U.S. Food and Drug Administration
Country
US

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.