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.),
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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- Bell Pharmaceuticals, Inc
- Product
- 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,
- Reason / hazard
- SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- U.S Nationwide
- Recall initiated
- 2026-06-25
- 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.
- Product quantity
- 106,301 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Belle Plaine
- State
- MN
- Country
- United States
- Event id
- 99278
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