Home/Recalls/FDA-D-0365-2026
FDA DrugsClass II

Medi-First Antiseptic Wipes (BZK)(Benzalkonium Chloride 0.13%), 100 wipes per bo...

Published: March 11, 2026Recall ID: D-0365-2026Category: drugsCountry: US

Reason for Recall / Hazard

CGMP Deviations

Product Description & Identification

Medi-First Antiseptic Wipes (BZK)(Benzalkonium Chloride 0.13%), 100 wipes per box, Manufactured for Medique Products, Fort Meyers, FL, 33967, NDC 47682-122-33.

Additional Source Details

FieldValue
CityShelton
StateCT
Openfda › Upc › 10347682214715
Openfda › Upc › 20347682130718
Openfda › UniiF5UM2KM3W7
Openfda › RouteTOPICAL
Openfda › Rxcui1038558
Openfda › Spl id3e4cc73e-7ce9-b648-e063-6394a90a6d33
Openfda › Brand nameMEDI-FIRST ANTISEPTIC WIPES
Openfda › Spl set idd31fe110-6d75-bf15-e053-2a95a90a8694
Openfda › Package ndc › 147682-122-99
Openfda › Package ndc › 247682-122-71
Openfda › Package ndc › 347682-122-33
Openfda › Package ndc › 447682-252-99
Openfda › Package ndc › 547682-252-71
Openfda › Product ndc › 147682-122
Openfda › Product ndc › 247682-252
Openfda › Generic nameBENZALKONIUM CHLORIDE
Openfda › Product typeHUMAN OTC DRUG
Openfda › Substance nameBENZALKONIUM CHLORIDE
Openfda › Manufacturer nameUnifirst First Aid Corporation
Openfda › Application numberM003
Openfda › Is original packagertrue
Event id98291
Address 11 Waterview Dr Ste 200
Address 2N/A
Code infoLot #: MN15922, Exp. Date Apr 2027; MN31022, Exp. Date Oct 2027; MN27223, Exp. Date 2028-Aug.
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