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-
Read the official notice at FDA (drug) →
Get alerts for Bell Pharmaceuticals
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
- 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.
- 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) 1505122, 1505343, expires: 2027-04; b) 1505142, 1505341, expires: 2027-04.
- Product quantity
- 16,156 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Belle Plaine
- State
- MN
- Country
- United States
- Event id
- 99278
Free daily digest + "My products" watchlist