ACME UNITED CORPORATION Class II Drug Recall D-0375-2026
Summary
The FDA has initiated a Class II drug recall for ACME UNITED CORPORATION's Dynarex BZK Antiseptic Towelettes due to CGMP deviations. The recall affects product distributed nationwide in the United States.
What changed
The Food and Drug Administration (FDA) has issued a Class II drug recall (D-0375-2026) for Dynarex BZK Antiseptic Towelettes manufactured for Dynarex Corporation. The recall is due to Current Good Manufacturing Practice (CGMP) deviations identified in the manufacturing process. The affected product, NDC 67777-245-01, was distributed nationwide within the United States.
This recall signifies a significant compliance issue for the manufacturer, potentially impacting product efficacy or safety. Companies involved in drug manufacturing must ensure strict adherence to CGMP regulations to prevent similar recalls. While specific compliance actions for Dynarex Corporation are ongoing, the nature of a Class II recall suggests a potential for adverse events, necessitating prompt corrective actions by the manufacturer and awareness among distributors and healthcare providers regarding the affected product.
What to do next
- Review CGMP compliance for antiseptic towelettes
- Verify product distribution records for affected lots
- Implement corrective actions to address CGMP deviations
Source document (simplified)
ACME UNITED CORPORATION
Drug Recalls (Class II)
← All Drug Recalls (Class II) Class II D-0375-2026 · 20260311 · Ongoing
Product
Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962,USA, NDC 67777-245-01
Reason for Recall
CGMP Deviations
Distribution
Nationwide within the United States
Source: openFDA Enforcement API
Related changes
Source
Classification
Who this affects
Taxonomy
Browse Categories
Get Pharma & Drug Safety alerts
Weekly digest. AI-summarized, no noise.
Free. Unsubscribe anytime.
Get alerts for this source
We'll email you when FDA: Drug Recalls Class II publishes new changes.