TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BULB & DROPS INCLUDED (NDC 36800-835-33); b) 1 bottle (NDC 36800-835-34), DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007.
USTopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BULB & DROPS INCLUDED (NDC 36800-835-33); b) 1 bottle (NDC 36800-835-34), DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007.
Recalling Firm: Bell Pharmaceuticals, Inc
Reason for Recall / Hazard
TranslatedSubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Product Description & Identification
TranslatedTopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BULB & DROPS INCLUDED (NDC 36800-835-33); b) 1 bottle (NDC 36800-835-34), DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007.
Additional Source Details
| Field | Value |
|---|---|
| City | Belle Plaine |
| State | MN |
| Openfda › Upc | 0036800776913 |
| Openfda › Unii | 31PZ2VAU81 |
| Openfda › Route | AURICULAR (OTIC) |
| Openfda › Rxcui | 702050 |
| Openfda › Spl id | 2f394074-9ba2-6dff-e063-6294a90a2cad |
| Openfda › Brand name | TOPCARE EARWAX REMOVAL KIT |
| Openfda › Spl set id | 890cc9b6-41a5-480a-bc94-45c8d4fdeef3 |
| Openfda › Package ndc › 1 | 36800-835-33 |
| Openfda › Package ndc › 2 | 36800-835-34 |
| Openfda › Product ndc | 36800-835 |
| Openfda › Generic name | CARBAMIDE PEROXIDE |
| Openfda › Product type | HUMAN OTC DRUG |
| Openfda › Substance name | CARBAMIDE PEROXIDE |
| Openfda › Manufacturer name | TOPCO ASSOCIATES LLC |
| Openfda › Application number | M014 |
| Openfda › Is original packager | true |
| Event id | 99278 |
| Address 1 | 200 W Beaver St |
| Code info | Lot: a) 1505122, 1505343, expires: 2027-04; b) 1505142, 1505341, expires: 2027-04. |
| Postal code | 56011-1894 |
| Report date | 20260722 |
| Product type | Drugs |
| Product quantity | 16,156 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 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Drugs).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BULB & DROPS INCLUDED (NDC 36800-835-33);...?
Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (FDA Drugs). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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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 - TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BULB & DROPS INCLUDED (NDC 36800-835-33); b) 1 bottle (NDC 36800-835-34), DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007. Check if your household is affected: https://therecallfile.com/recalls/topcare-health-carbamide-peroxide-6-5-0-5-fl-oz-15-ml-a-kit-washer-bul/FDA-D-0681-2026
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