ACME UNITED CORPORATION Class II Drug Recall
Summary
The FDA has issued a Class II recall for ACME UNITED CORPORATION's Hand Sanitizing Wipes due to CGMP deviations. The recall, identified as D-0373-2026, is ongoing and 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 Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%). The recall, designated D-0373-2026, is due to Current Good Manufacturing Practice (CGMP) deviations. The product, identified by NDC 0924-0301-00 and packaged 1000 per case, was distributed nationwide within the United States.
This recall signifies a significant compliance issue for ACME UNITED CORPORATION, requiring immediate attention to product disposition and corrective actions. Companies in the pharmaceutical and consumer health sectors should review their CGMP compliance, particularly concerning hand sanitizing products, to prevent similar deviations. While no specific compliance deadline is stated, the ongoing nature of the recall implies that corrective actions and product recovery are actively underway.
What to do next
- Review CGMP compliance for hand sanitizing products
- Assess product disposition and recovery for affected batches
Source document (simplified)
ACME UNITED CORPORATION
Drug Recalls (Class II)
← All Drug Recalls (Class II) Class II D-0373-2026 · 20260311 · Ongoing
Product
Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 1000 per case, Acme United Corporation, 2280 Tanner Road, Rocky Mount, NC 27801, NDC 0924-0301-00
Reason for Recall
CGMP Deviations
Distribution
Nationwide within the United States
Source: openFDA Enforcement API
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