FDA DrugsClass II
Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5x7, 1000 pack...
Published: March 11, 2026Recall ID: D-0376-2026Category: drugsCountry: US
Reason for Recall / Hazard
CGMP Deviations
Product Description & Identification
Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5x7, 1000 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962,USA, NDC 67777-245-04.
Additional Source Details
| Field | Value |
|---|---|
| City | Shelton |
| State | CT |
| Openfda › Upc › 1 | 0616784133225 |
| Openfda › Upc › 2 | 0840117329331 |
| Openfda › Upc › 3 | 0840117329355 |
| Openfda › Upc › 4 | 0616784133324 |
| Openfda › Upc › 5 | 0616784130323 |
| Openfda › Upc › 6 | 0840117329379 |
| Openfda › Upc › 7 | 0616784133133 |
| Openfda › Unii | F5UM2KM3W7 |
| Openfda › Route | TOPICAL |
| Openfda › Rxcui | 1038558 |
| Openfda › Spl id | 49740b5f-0caa-2aa7-e063-6394a90a36e9 |
| Openfda › Brand name | BZK PADS |
| Openfda › Spl set id | 1409c437-ff17-481d-94be-87dd6d463ba9 |
| Openfda › Package ndc › 1 | 67777-245-01 |
| Openfda › Package ndc › 2 | 67777-245-11 |
| Openfda › Package ndc › 3 | 67777-245-02 |
| Openfda › Package ndc › 4 | 67777-245-14 |
| Openfda › Package ndc › 5 | 67777-245-04 |
| Openfda › Package ndc › 6 | 67777-245-15 |
| Openfda › Package ndc › 7 | 67777-245-05 |
| Openfda › Package ndc › 8 | 67777-245-06 |
| Openfda › Package ndc › 9 | 67777-245-16 |
| Openfda › Package ndc › 10 | 67777-245-08 |
| Openfda › Package ndc › 11 | 67777-245-18 |
| Openfda › Package ndc › 12 | 67777-245-07 |
| Openfda › Package ndc › 13 | 67777-245-17 |
| Openfda › Product ndc | 67777-245 |
| Openfda › Generic name | BENZALKONIUM CHLORIDE |
| Openfda › Product type | HUMAN OTC DRUG |
| Openfda › Substance name | BENZALKONIUM CHLORIDE |
| Openfda › Manufacturer name | Dynarex 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 #: 53518, 53519, Exp. Date Jun 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