ACME UNITED CORPORATION Class II Recall for Alcohol Hand Wipe
Summary
The FDA has initiated a Class II recall for ACME UNITED CORPORATION's Antimicrobial Alcohol Hand Wipe due to CGMP deviations. The recall affects product distributed nationwide in the United States and is currently ongoing.
What changed
The FDA has issued a Class II recall for ACME UNITED CORPORATION's Antimicrobial Alcohol Hand Wipes (Isopropyl Alcohol 70%, NDC 0924-251-00) due to Current Good Manufacturing Practice (CGMP) deviations. The recall, identified by docket number D-0378-2026, is ongoing and impacts product distributed nationwide.
Manufacturers and distributors of this product must immediately cease distribution and implement recall procedures. Compliance officers should review their CGMP adherence, particularly concerning manufacturing processes and quality control, to prevent similar issues. While specific penalties are not detailed, failure to comply with recall orders can result in significant regulatory action and reputational damage.
What to do next
- Cease distribution of affected product
- Implement recall procedures as per FDA guidelines
- Review internal CGMP compliance and quality control processes
Source document (simplified)
ACME UNITED CORPORATION
Drug Recalls (Class II)
← All Drug Recalls (Class II) Class II D-0378-2026 · 20260311 · Ongoing
Product
Antimicrobial Alcohol Hand Wipe, Isopropyl Alcohol 70%, Manufactured for : Custom Packaging Co., Inc, Louisville, KY 4023, NDC 0924-251-00.
Reason for Recall
CGMP Deviations
Distribution
Nationwide within the United States
Source: openFDA Enforcement API
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