Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL) 6.5%, 0.5 fl. oz. (15 mL); b) 1 bottle of Clinere Carbamide Peroxide (0,50 fl. oz. (15 mL), Dist. by: Quest Products LLC, Pleasant Prairie, WI 53158, NDC 68229-102-01.
USClinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL) 6.5%, 0.5 fl. oz. (15 mL); b) 1 bottle of Clinere Carbamide Peroxide (0,50 fl. oz. (15 mL), Dist. by: Quest Products LLC, Pleasant Prairie, WI 53158, NDC 68229-102-01.
Recalling Firm: Bell Pharmaceuticals, Inc
Reason for Recall / Hazard
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Product Description & Identification
Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL) 6.5%, 0.5 fl. oz. (15 mL); b) 1 bottle of Clinere Carbamide Peroxide (0,50 fl. oz. (15 mL), Dist. by: Quest Products LLC, Pleasant Prairie, WI 53158, NDC 68229-102-01.
Additional Source Details
| Field | Value |
|---|---|
| City | Belle Plaine |
| State | MN |
| Openfda › Unii | 31PZ2VAU81 |
| Openfda › Route | AURICULAR (OTIC) |
| Openfda › Rxcui | 702050 |
| Openfda › Spl id | 47e36138-722e-d71c-e063-6294a90a808e |
| Openfda › Brand name | CLINERE EAR WAX REMOVER |
| Openfda › Spl set id | d967eac3-0aac-a7ae-e053-2995a90a0e1e |
| Openfda › Package ndc › 1 | 68229-102-01 |
| Openfda › Package ndc › 2 | 68229-102-03 |
| Openfda › Package ndc › 3 | 68229-102-02 |
| Openfda › Product ndc | 68229-102 |
| Openfda › Generic name | CARBAMIDE PEROXIDE |
| Openfda › Product type | HUMAN OTC DRUG |
| Openfda › Substance name | CARBAMIDE PEROXIDE |
| Openfda › Manufacturer name | Quest Products |
| Openfda › Application number | M014 |
| Openfda › Is original packager | true |
| Event id | 99278 |
| Address 1 | 200 W Beaver St |
| Code info | Lot: a) 1504241, exp 2027-03; b) 1504291, 1504301, exp 2027-03. |
| Postal code | 56011-1894 |
| Report date | 20260722 |
| Product type | Drugs |
| Product quantity | 29, 474 units |
| Reason for recall | SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260625 |
| Initial firm notification | Letter |
| Center classification date | 20260714 |
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Overview
- Recalling FirmBell Pharmaceuticals, Inc
- StatusOngoing
- Risk LevelClass II
- DistributionU.S Nationwide
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🚨 SAFETY ALERT: Bell Pharmaceuticals, Inc - Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL) 6.5%, 0.5 fl. oz. (15 mL); b) 1 bottle of Clinere Carbamide Peroxide (0,50 fl. oz. (15 mL), Dist. by: Quest Products LLC, Pleasant Prairie, WI 53158, NDC 68229-102-01. Check if your household is affected: https://therecallfile.com/recalls/clinere-carbamide-peroxide-a-2-bottles-of-clinere-carbamide-peroxide-2/FDA-D-0679-2026
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