FDA DrugsClass II
First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 50 Wipes...
Published: March 11, 2026Recall ID: D-0359-2026Category: drugsCountry: US
Reason for Recall / Hazard
CGMP Deviations
Product Description & Identification
First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 50 Wipes, NDC 0924-7116-03.
Additional Source Details
| Field | Value |
|---|---|
| City | Shelton |
| State | CT |
| Openfda › Upc | 0092265083072 |
| Openfda › Unii | F5UM2KM3W7 |
| Openfda › Route | TOPICAL |
| Openfda › Spl id | 2488e41a-56e3-f4ab-e063-6394a90a2700 |
| Openfda › Brand name | FIRST AID ONLY BZK ANTISEPTIC |
| Openfda › Spl set id | dbed7ed6-a9b8-7b59-e053-2a95a90ac0cb |
| Openfda › Package ndc › 1 | 0924-7116-00 |
| Openfda › Package ndc › 2 | 0924-7116-04 |
| Openfda › Package ndc › 3 | 0924-7116-05 |
| Openfda › Package ndc › 4 | 0924-7116-03 |
| Openfda › Package ndc › 5 | 0924-7116-01 |
| Openfda › Package ndc › 6 | 0924-7116-02 |
| Openfda › Product ndc | 0924-7116 |
| 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 #: MN34722, MN34722, Exp. Date Nov 2027; MN34722B, Exp. Date Aug 2027. |
| 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