Antimicrobial alcohol hand wipes recalled over manufacturing practice deviations
Acme United Corporation is recalling Antimicrobial Alcohol Hand Wipes containing 70% isopropyl alcohol over current good manufacturing practice deviations.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Rubric level 2 covers voluntary precautionary recalls: this is a firm-initiated recall over manufacturing practice deviations with no hazard, illness or injury described in the source.
Plain-English summary
Acme United Corporation is recalling Antimicrobial Alcohol Hand Wipe, Isopropyl Alcohol 70%, made for Custom Packaging Co., Inc of Louisville, Kentucky, NDC 0924-251-00. The product was distributed nationwide within the United States. The FDA has classified this recall as Class II, and the firm initiated it voluntarily.
The recall was initiated for CGMP deviations. The source record does not describe a specific hazard, illness or injury.
Affected product covers lots MN15423, MN16422, MN26322, MN03423, MN09722, MN31722, MN15722 and MN13722, with expiry dates from March 2027 to January 2028.
Users can identify affected product by the NDC and lot numbers above, and may contact Acme United Corporation for further information.
The recalled product
- Product
- Antimicrobial Alcohol Hand Wipe, Isopropyl Alcohol 70%, Manufactured for : Custom Packaging Co., Inc, Louisville, KY 4023, NDC 0924-251-00.
- Manufacturer
- ACME UNITED CORPORATION
- Category
- Drug — Topical antiseptic
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- Lot #: MN15423
- MN16422
- Exp. Date Apr 2027-Apr
- MN26322
- Exp. Date Aug 2027
- MN03423
- Exp. Date Jan 2028
- MN09722
- Exp. Date Mar 2027
- MN31722
- Exp. Date Oct 2027
- MN15722
- MN13722 Exp. Date Apr 2027
- Exp. Date Oct 2027
- Exp. Date Mar 2027.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 21 recalled by ACME UNITED CORPORATION under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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