AUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) a) Kit - Washer Bulb Included (NDC 59256-001-02); b) 1 bottle (NDC 59256-836-34), Distributed By: Oaktree Products Inc., St. Louis. MO 63005.
USAUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) a) Kit - Washer Bulb Included (NDC 59256-001-02); b) 1 bottle (NDC 59256-836-34), Distributed By: Oaktree Products Inc., St. Louis. MO 63005.
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
AUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) a) Kit - Washer Bulb Included (NDC 59256-001-02); b) 1 bottle (NDC 59256-836-34), Distributed By: Oaktree Products Inc., St. Louis. MO 63005.
Affected Products
AUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) a) Kit - Washer Bulb Included (NDC 59256-001-02); b) 1 bottle (NDC 59256-836-34), Distributed By: Oaktree Products Inc., St. Louis. MO 63005.
Additional Source Details
| Field | Value |
|---|---|
| City | Belle Plaine |
| State | MN |
| Openfda › Upc › 1 | 0749566001020 |
| Openfda › Upc › 2 | 0749566001013 |
| Openfda › Unii | 31PZ2VAU81 |
| Openfda › Route › 1 | TOPICAL |
| Openfda › Route › 2 | AURICULAR (OTIC) |
| Openfda › Rxcui | 702050 |
| Openfda › Spl id › 1 | 52f59193-51cf-ad22-e063-6394a90a248a |
| Openfda › Spl id › 2 | 2f3946af-a3da-7032-e063-6294a90ad132 |
| Openfda › Brand name › 1 | AUDIOLOGISTS CHOICE EARWAX REMOVAL SYSTEM |
| Openfda › Brand name › 2 | AUDIOLOGISTS CHOICE EARWAX REMOVAL AID DROPS |
| Openfda › Spl set id › 1 | c9ad507b-341c-474f-aaa2-3c3a97a30dd8 |
| Openfda › Spl set id › 2 | 2922dde2-d082-437b-8f51-4a91ced20a58 |
| Openfda › Package ndc › 1 | 59256-001-02 |
| Openfda › Package ndc › 2 | 59256-836-34 |
| Openfda › Product ndc › 1 | 59256-001 |
| Openfda › Product ndc › 2 | 59256-836 |
| Openfda › Generic name | CARBAMIDE PEROXIDE |
| Openfda › Product type | HUMAN OTC DRUG |
| Openfda › Substance name | CARBAMIDE PEROXIDE |
| Openfda › Manufacturer name › 1 | Oaktree Products Inc. |
| Openfda › Manufacturer name › 2 | Oaktree Products Inc |
| Openfda › Application number | M014 |
| Openfda › Is original packager | true |
| Event id | 99278 |
| Address 1 | 200 W Beaver St |
| Code info | Lot: a)1505123, expires: 2027-04; b) 1505131, expires: 2027-04. |
| Postal code | 56011-1894 |
| Report date | 20260722 |
| Product type | Drugs |
| Product quantity | 5,762 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 - AUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) a) Kit - Washer Bulb Included (NDC 59256-001-02); b) 1 bottle (NDC 59256-836-34), Distributed By: Oaktree Products Inc., St. Louis. MO 63005. Check if your household is affected: https://therecallfile.com/recalls/audiologist-s-choice-carbamide-peroxide-6-5-0-5-fl-oz-15-ml-a-kit-wash/FDA-D-0682-2026
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