ACME UNITED CORPORATION Class II Drug Recall
Summary
The FDA has initiated a Class II drug recall for ACME UNITED CORPORATION's Max Packaging Antibacterial Towelette due to CGMP deviations. The recall affects product distributed nationwide within the United States and is ongoing.
What changed
The Food and Drug Administration (FDA) has issued a Class II drug recall for ACME UNITED CORPORATION's Max Packaging Antibacterial Towelette (Benzalkonium Chloride 0.13%), NDC 59647-750-01. The recall is due to Current Good Manufacturing Practice (CGMP) deviations identified by the agency. This action signifies a significant regulatory event for the manufacturer, requiring immediate attention to product removal and corrective actions.
ACME UNITED CORPORATION must manage the recall process, which includes notifying distributors and potentially consumers about the affected product. Compliance officers should verify the scope of distribution and ensure adherence to FDA recall procedures. While specific penalties are not detailed, failure to comply with recall directives can result in further enforcement actions. The recall is marked as 'Ongoing,' indicating that the process is currently active and requires monitoring.
What to do next
- Verify recall scope and distribution channels
- Ensure adherence to FDA recall procedures
- Implement corrective actions to address CGMP deviations
Source document (simplified)
ACME UNITED CORPORATION
Drug Recalls (Class II)
← All Drug Recalls (Class II) Class II D-0363-2026 · 20260311 · Ongoing
Product
Max Packaging Antibacterial Towelette (Benzalkonium Chloride 0.13%), 1 towelette, 4x7, Max Packaging, Made in the USA, NDC 59647-750-01
Reason for Recall
CGMP Deviations
Distribution
Nationwide within the United States
Source: openFDA Enforcement API
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