CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.); b) Kit (1 BULB, Syringe & Drops- NDC 51316-823-00.), Distributed by: CVS Pharmacy., Inc. One CVS Drive, Woonsocket, RI 02895,
USCVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.); b) Kit (1 BULB, Syringe & Drops- NDC 51316-823-00.), Distributed by: CVS Pharmacy., Inc. One CVS Drive, Woonsocket, RI 02895,
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
CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.); b) Kit (1 BULB, Syringe & Drops- NDC 51316-823-00.), Distributed by: CVS Pharmacy., Inc. One CVS Drive, Woonsocket, RI 02895,
Additional Source Details
| Field | Value |
|---|---|
| City | Belle Plaine |
| State | MN |
| Openfda › Upc | 0050428078273 |
| Openfda › Unii | 31PZ2VAU81 |
| Openfda › Route | TOPICAL |
| Openfda › Rxcui | 702050 |
| Openfda › Spl id › 1 | 1ba4260c-f726-77de-e063-6294a90ab529 |
| Openfda › Spl id › 2 | 52f5c6f4-95ea-d093-e063-6394a90a037c |
| Openfda › Brand name › 1 | CVS HEALTH EARWAX REMOVAL DROPS EARWAX REMOVAL AID |
| Openfda › Brand name › 2 | CVS HEALTH EARWAX REMOVAL KIT |
| Openfda › Spl set id › 1 | 42a22e06-1b66-4359-852c-7c39e1b3940a |
| Openfda › Spl set id › 2 | f842534c-46dd-42c7-8386-9a03ce16da86 |
| Openfda › Package ndc › 1 | 51316-822-00 |
| Openfda › Package ndc › 2 | 51316-823-00 |
| Openfda › Product ndc › 1 | 51316-822 |
| Openfda › Product ndc › 2 | 51316-823 |
| Openfda › Generic name | CARBAMIDE PEROXIDE |
| Openfda › Product type | HUMAN OTC DRUG |
| Openfda › Substance name | CARBAMIDE PEROXIDE |
| Openfda › Manufacturer name | CVS Pharmacy, Inc. |
| Openfda › Application number | M014 |
| Openfda › Is original packager | true |
| Event id | 99278 |
| Address 1 | 200 W Beaver St |
| Code info | Lot: a) 1505121, 1504242, exp 2027-03; 1505132, 1505182, 1505191, 1505291, 1505331, exp 2027-04; b) 1504231, 1504311, exp 2027-03; 1505312, 1505321, exp 2027-04. |
| Postal code | 56011-1894 |
| Report date | 20260722 |
| Product type | Drugs |
| Product quantity | 106,301 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 - CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.); b) Kit (1 BULB, Syringe & Drops- NDC 51316-823-00.), Distributed by: CVS Pharmacy., Inc. One CVS Drive, Woonsocket, RI 02895, Check if your household is affected: https://therecallfile.com/recalls/cvs-health-carbamide-peroxide-6-5-0-5-fl-oz-15-ml-a-bottle-ndc-51316-8/FDA-D-0678-2026
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SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).