FDA DrugsClass II
First Aid Only BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%), 5x7, bulk...
Published: March 11, 2026Recall ID: D-0361-2026Category: drugsCountry: US
Reason for Recall / Hazard
CGMP Deviations
Product Description & Identification
First Aid Only BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%), 5x7, bulk, Acme United Corporation, 2280 Tanner Road, Rocky Mount, NC, 27801 Made in USA, NDC 0924-7116-00.
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 #: MN12121, MN13521, Exp. Date Apr 2026; MN15221, MN16721, MN16921, MN17021, MN17021B, Exp. Date May 2026; MN18521, MN18621, MN18621B, Exp. Date Jun 2026; MN24721, MN25021, Exp. Date Aug 2026; MN01123, Exp. Date Dec 2027; MN27421, MN27721, Exp. Date Sep 2026; MN31321, MN31421, Exp. Date Oct 2026; MN34321, MN34521, MN34721, Exp. Date Nov 2026; MN02022, MN03022, Exp. Date Dec 2026; MN03522, MN04622, Exp. Date Jan 2027; MN06022, MN06122, Exp. Date Feb 2027; MN12322, MN12422, MN14422, Exp. Date Apr 2027; MN15322, Exp. May 2027; MN22022, Exp. Date Jul 2027; MN25222, MN25322, MN26422, Exp. Date Aug 2027; MN27822, Exp. Date Sep 2027; MN15322, Exp. Date Nov 2027; MN06123, Exp. Date Aug 2027; MN06423, MN06523, Exp. Date Feb 2028; MN09423, MN09523, MN09723, MN10223 Exp Date Mar 2028; MN12623, MN13323, Exp. Date Apr 2028; MN15322, MN16523, Exp. Date May 2028; MN18623, MN19323, MN19423, MN20223, Exp. Date Jun 2028; MN24323, MN24423 Exp. Date Jul 2028; MN34523, Exp. Date Nov 2028; 301424... [TRUNCATED] |
| 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