Home/Recalls/FDA-D-0373-2026
FDA DrugsClass II

Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 1000 per case, Acme United ...

Published: March 11, 2026Recall ID: D-0373-2026Category: drugsCountry: US

Reason for Recall / Hazard

CGMP Deviations

Product Description & Identification

Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 1000 per case, Acme United Corporation, 2280 Tanner Road, Rocky Mount, NC 27801, NDC 0924-0301-00

Additional Source Details

FieldValue
CityShelton
StateCT
Openfda › UniiND2M416302
Openfda › RouteTOPICAL
Openfda › Rxcui797544
Openfda › Spl id27d88cfa-6cd2-403e-e063-6394a90a8088
Openfda › Brand nameFIRST AID ONLY HAND SANITIZING WIPE
Openfda › Spl set id03ec9021-816f-970c-e063-6294a90a6732
Openfda › Package ndc › 10924-0301-00
Openfda › Package ndc › 20924-0301-04
Openfda › Package ndc › 30924-0301-05
Openfda › Product ndc0924-0301
Openfda › Generic nameISOPROPYL ALCOHOL
Openfda › Product typeHUMAN OTC DRUG
Openfda › Substance nameISOPROPYL ALCOHOL
Openfda › Manufacturer nameAcme United Corporation
Openfda › Application number505G(a)(3)
Openfda › Is original packagertrue
Event id98291
Address 11 Waterview Dr Ste 200
Address 2N/A
Code infoLot #: MN24922, Exp. Date Aug 2027; MN31122, Exp. Date Oct 2027.
Postal code06484-4368
Report date20260311
Product typeDrugs
Product quantityN/A
Reason for recallCGMP Deviations
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260120
Initial firm notificationLetter
Center classification date20260302

Overview

  • Recalling FirmACME UNITED CORPORATION
  • StatusOngoing
  • Risk LevelClass II
  • DistributionNationwide within the United States
Official Agency Alert