ACME UNITED CORPORATION Class II Recall: BZK Antiseptic Towelettes
Summary
The FDA has initiated a Class II recall for ACME UNITED CORPORATION's BZK Antiseptic Towelettes due to CGMP deviations. The recall affects product distributed nationwide within the United States.
What changed
The Food and Drug Administration (FDA) has issued a Class II recall for ACME UNITED CORPORATION's BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%, NDC 0924-0246-02). This action is due to Current Good Manufacturing Practice (CGMP) deviations identified by the agency. The affected product was distributed nationwide across the United States.
Companies involved in the manufacturing or distribution of these antiseptic towelettes must immediately review their CGMP compliance and recall procedures. While specific compliance deadlines are not detailed, the nature of a Class II recall necessitates prompt action to ensure product safety and adherence to regulatory standards. Failure to comply with recall procedures can result in further enforcement actions by the FDA.
What to do next
- Review CGMP compliance for antiseptic towelette manufacturing.
- Implement recall procedures for affected product batches.
- Ensure adherence to FDA recall guidelines.
Source document (simplified)
ACME UNITED CORPORATION
Drug Recalls (Class II)
← All Drug Recalls (Class II) Class II D-0367-2026 · 20260311 · Ongoing
Product
BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5" x7", 1000 ea Bulk, Med-Nap, Brooksville, FL 34601, Made in USA, NDC 0924-0246-02.
Reason for Recall
CGMP Deviations
Distribution
Nationwide within the United States
Source: openFDA Enforcement API
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