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🏥 FDA: ACME UNITED CORPORATION — Class II

healthcarebearishSource: FDA
90%Confidence
0Views
FDASource
2026-03-17Date

Summary

Additional Acme United CGMP violations for bulk antiseptic towelettes confirm systemic manufacturing problems across their entire product range, increasing likelihood of FDA enforcement actions. The bulk packaging issue suggests problems may affect institutional healthcare customers.

Actionable: Immediately suspend procurement of all Acme United antiseptic products until comprehensive remediation is verified.

AI Confidence: 90%

Data Points

firmACME UNITED CORPORATION
classificationClass II
statusOngoing
distributionNationwide within the United States
productFirst Aid Only BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%), 5x7, bulk, Acme United Corporation, 2280 Tanner Road, Rocky Mount, NC, 27801 Ma

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