80%Confidence
0Views
FDASource
2026-03-21Date
Summary
Dynarex-branded antiseptic towelettes manufactured by Acme United face CGMP deviations, indicating quality control problems that extend beyond Acme's proprietary brands. This could affect Dynarex's product reliability and may lead to contract manufacturing relationship strains between the two companies.
Actionable: Assess Dynarex's quality oversight of contract manufacturers and consider alternative antiseptic wipe suppliers.
AI Confidence: 80%
Data Points
firmACME UNITED CORPORATION
classificationClass II
statusOngoing
distributionNationwide within the United States
productDynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5x7, 1000 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Or
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