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Drug FDA Class II Ongoing Contamination / non-sterility

MAXIM Assure Antibacterial, Chloroxylenol 0.1%, Net Contents: One U.S. Gallon (3.78 L), For Industrial and Institutional Use Only, MIDLAB 140 Private Brand Way, Athens, TN 37303

Midlab Incorporated Published Dec 11, 2024

Risk level

Class II

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

Severity score 60/100

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 Midlab Incorporated or your place of purchase with questions, and see the source record below for full details.
Reason for recall

cGMP Deviations: Out of specification results for micro in hand soap products.

Hazards

Microbial contamination · primary

Affected products (1)

MAXIM Assure Antibacterial, Chloroxylenol 0.1%, Net Contents: One U.S. Gallon (3.78 L), For Industrial and Institutional Use Only, MIDLAB 140 Private Brand Way, Athens, TN 37303
Lot codes: 0711241
Code info: Lot 0711241

Affected areas

Nationwide

Timeline

  1. Initiated
    Nov 6, 2024
  2. Published
    Dec 11, 2024
Recall number
D-0087-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

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.