ACME UNITED CORPORATION Class II Recall of Antiseptic Wipes
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
- Review inventory for affected product (Medi-First Antiseptic Wipes, NDC 47682-122-33).
- Consult FDA guidance on Class II recalls and CGMP deviations.
- 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
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