Class II · Moderate risk
Revitaderm Wound Care
CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
Hand Sanitizing Wipes (Isopropyl Alcohol)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 1000 per case, Acme United Corporation, 2280 Tanner Road, Rocky Mount, NC 27801, NDC 0924-0301-00
Affected NDC
0924-0301-00
Compare with the code on your package — it is the most precise check available.
Drug: Benzalkonium
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| First Aid Only Hand Sanitizing Wipe Isopropyl Alcohol NDC 00924-0301 |
70 mL/100mL | Swab Topical |
Acme United Corporation | OTC |
- Recalling firm
- Acme United Corporation
- NDC code
- 0924-0301-00
- Origin
- CT, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0373-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Benzalkonium recalls
See all
Class II · Moderate risk
TRIFLUENT PHARMA TRIDERGEL Wound Care Gel
CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated
Class I · High risk
Revitaderm Wound Care Gel
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp
Class III · Low risk
Lidocaine Wound Gel
Failed PH Specifications
Class II · Moderate risk
Children's Healthcare of Atlanta
CGMP Deviations
Other recalls by Acme United Corporation
All 2026 recalls
Class II · Moderate risk
Antimicrobial Alcohol Hand Wipe
CGMP Deviations
Class II · Moderate risk
Children's Healthcare of Atlanta
CGMP Deviations
Class II · Moderate risk
Dynarex
CGMP Deviations
Class II · Moderate risk
Dynarex
CGMP Deviations
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