FDA DrugsClass II
BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5" x7", 1000 ea Bulk, M...
Published: March 11, 2026Recall ID: D-0367-2026Category: drugsCountry: US
Reason for Recall / Hazard
CGMP Deviations
Product Description & Identification
BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5" x7", 1000 ea Bulk, Med-Nap, Brooksville, FL 34601, Made in USA, NDC 0924-0246-02.
Additional Source Details
| Field | Value |
|---|---|
| City | Shelton |
| State | CT |
| Openfda › Upc | 0092265940061 |
| Openfda › Unii | F5UM2KM3W7 |
| Openfda › Route | TOPICAL |
| Openfda › Spl id | 2682a042-f9ba-30dc-e063-6394a90a9e33 |
| Openfda › Brand name | MED NAP BENZALKONIUM CHLORIDE ANTISEPTIC |
| Openfda › Spl set id | d7c404c1-c765-a67c-e053-2995a90a6b8e |
| Openfda › Package ndc › 1 | 0924-0246-00 |
| Openfda › Package ndc › 2 | 0924-0246-01 |
| Openfda › Package ndc › 3 | 0924-0246-02 |
| Openfda › Package ndc › 4 | 0924-0246-03 |
| Openfda › Product ndc | 0924-0246 |
| Openfda › Generic name | BENZALKONIUM CHLORIDE |
| Openfda › Product type | HUMAN OTC DRUG |
| Openfda › Substance name | BENZALKONIUM CHLORIDE |
| Openfda › Manufacturer name | Acme United Corporation |
| Openfda › Application number | M003 |
| Openfda › Is original packager | true |
| Event id | 98291 |
| Address 1 | 1 Waterview Dr Ste 200 |
| Address 2 | N/A |
| Code info | Lot # MN23323, Exp. Date Jul 2028; MN31323, Exp. Date Oct 2028; MN21622, Exp. Date Jul 2027; MN13123, Exp. Date Apr 2028. |
| Postal code | 06484-4368 |
| Report date | 20260311 |
| Product type | Drugs |
| Product quantity | N/A |
| Reason for recall | CGMP Deviations |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260120 |
| Initial firm notification | Letter |
| Center classification date | 20260302 |
Overview
- Recalling FirmACME UNITED CORPORATION
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide within the United States