90%Confidence
1Views
FDASource
2026-03-22Date
Summary
Acme United's multiple Class II recalls across antiseptic towelette products reveal systemic CGMP deviations that could lead to regulatory scrutiny and potential market share loss. The recurring nature of these violations across different product lines and customers suggests deeper quality management issues within the company's manufacturing operations.
Actionable: Evaluate exposure to Acme United's manufacturing facilities and consider diversifying antiseptic product sourcing.
AI Confidence: 90%
Data Points
firmACME UNITED CORPORATION
classificationClass II
statusOngoing
distributionNationwide within the United States
productMed Nap BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manufactured by: Acme United Corporation, 1 Waterview Dr, Shelton, CT
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