FDARecalled Jul 22, 2026 · #D-0685-2026
LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL OZ DROPS, (NDC 70000-0689-1); b) 1 bottle (NDC 70000-0688-1), DIST. BY CARDINAL HEALTH, DUBLIN, OH 43017.
Hazard
Class II — temporary health risk
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SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). Classification: Class II Distribution: U.S Nationwide
Product details
- Product
- LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL OZ DROPS, (NDC 70000-0689-1); b) 1 bottle (NDC 70000-0688-1), DIST. BY CARDINAL HEALTH, DUBLIN, OH 43017.
- Type
- Drugs
- Manufacturer
- Bell Pharmaceuticals, Inc
- Model numbers
- —
- UPCs
- —