Changeflow GovPing Pharma & Drug Safety ACME UNITED CORPORATION Class II Recall of Anti...
Urgent Enforcement Added Final

ACME UNITED CORPORATION Class II Recall of Antiseptic Wipes

Favicon for changeflow.com FDA: Drug Recalls Class II
Filed March 11th, 2026
Detected March 28th, 2026
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Summary

The FDA has announced a Class II recall for ACME UNITED CORPORATION's Medi-First Antiseptic Wipes due to CGMP deviations. The recall affects product distributed nationwide in the United States.

What changed

The Food and Drug Administration (FDA) has initiated a Class II recall for ACME UNITED CORPORATION's Medi-First Antiseptic Wipes (Benzalkonium Chloride 0.13%). The recall is due to Current Good Manufacturing Practice (CGMP) deviations identified by the agency. The affected product, NDC 47682-122-33, was manufactured for Medique Products and distributed nationwide.

This recall signifies a significant compliance issue for the manufacturer, highlighting potential risks to product quality and patient safety. Companies involved in drug manufacturing must ensure strict adherence to CGMP regulations to prevent similar enforcement actions. While no specific compliance deadline is mentioned, affected parties should review their own manufacturing processes and inventory for similar deviations and consult FDA guidance on recall procedures.

What to do next

  1. Review inventory for affected product (Medi-First Antiseptic Wipes, NDC 47682-122-33).
  2. Consult FDA guidance on Class II recalls and CGMP deviations.
  3. Assess internal CGMP compliance to prevent recurrence.

Source document (simplified)

ACME UNITED CORPORATION

Drug Recalls (Class II)

← All Drug Recalls (Class II) Class II D-0365-2026 · 20260311 · Ongoing

Product

Medi-First Antiseptic Wipes (BZK)(Benzalkonium Chloride 0.13%), 100 wipes per box, Manufactured for Medique Products, Fort Meyers, FL, 33967, NDC 47682-122-33.

Reason for Recall

CGMP Deviations

Distribution

Nationwide within the United States

Source: openFDA Enforcement API

Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
FDA
Filed
March 11th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
D-0365-2026

Who this affects

Applies to
Drug manufacturers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Drug Manufacturing Product Recalls
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Compliance
Compliance frameworks
FDA 21 CFR Part 11 GxP
Topics
Product Safety Pharmaceuticals

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