FDA Class II Recall of Antiseptic Wipes
Summary
The FDA has initiated a Class II recall for Green Guard Antiseptic Wipes due to CGMP deviations. The product was distributed nationwide in the United States. This recall is ongoing.
What changed
The Food and Drug Administration (FDA) has classified a recall of Green Guard Antiseptic Wipes (Benzalkonium Chloride 0.13%) as Class II, identified by docket number D-0374-2026. The reason for the recall is cited as Current Good Manufacturing Practice (CGMP) deviations. The product, distributed nationwide, includes specific lot information and NDC number 47682-056-73.
This action signifies a significant compliance issue for the manufacturer and distributor, ACME UNITED CORPORATION. Companies involved in the distribution chain must ensure affected products are identified and removed from circulation. While specific penalties are not detailed, CGMP deviations can lead to regulatory scrutiny and potential future enforcement actions if not adequately addressed. The ongoing nature of the recall suggests active management of the issue by the responsible parties.
What to do next
- Identify and remove affected Green Guard Antiseptic Wipes from inventory and patient use.
- Review internal CGMP compliance to prevent recurrence.
- Consult FDA recall guidelines for specific reporting and remediation steps.
Source document (simplified)
ACME UNITED CORPORATION
Drug Recalls (Class II)
← All Drug Recalls (Class II) Class II D-0374-2026 · 20260311 · Ongoing
Product
Green Guard Antiseptic Wipes (Benzalkonium Chloride 0.13%), 25 wipes per box, Distributed by Green Guard, St. Louis, MO 63045, NDC 47682-056-73
Reason for Recall
CGMP Deviations
Distribution
Nationwide within the United States
Source: openFDA Enforcement API
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