FDA DrugsClass II
Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%), 100 packe...
Published: March 11, 2026Recall ID: D-0369-2026Category: drugsCountry: US
Reason for Recall / Hazard
CGMP Deviations
Product Description & Identification
Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%), 100 packets, 5" x 7", Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, USA Made in USA, NDC 67777-244-02
Additional Source Details
| Field | Value |
|---|---|
| City | Shelton |
| State | CT |
| Openfda › Unii | F5UM2KM3W7 |
| Openfda › Route | TOPICAL |
| Openfda › Rxcui | 1038558 |
| Openfda › Spl id | 490f7b25-5739-2e09-e063-6394a90aaa37 |
| Openfda › Brand name | BZK PADS |
| Openfda › Spl set id | 10454042-ff2e-44ce-b2e2-436cc004897f |
| Openfda › Package ndc › 1 | 67777-244-02 |
| Openfda › Package ndc › 2 | 67777-244-01 |
| Openfda › Product ndc | 67777-244 |
| 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 #: 52347-R, 52348-R, 52349-R, 52350-R, 52351-R, 52352-R, 53518, 53519, Exp. Date Mar 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