Status
Ongoing
Drug Enforcement D-0433-2025
CGMP Deviations
Classification
Class II
Report Date
May 28, 2025
Termination Date
—
Product Information
- Product description
- Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 0.15 OZ (4.25 g) Sachets, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-01
- Product quantity
- 1,559,000 Sachets
- Reason for recall
- CGMP Deviations
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- DE and NC
Location & Firm
- Recalling firm
- KENIL HEALTHCARE PRIVATE LIMITED
- Address
-
Plot 319, Village Acharasan, Ankhol-Vamaj Road
India - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0433-2025
- Event ID
- 96797
- Recall initiation date
- April 24, 2025
- Center classification date
- May 19, 2025
- Code info
- Lot B0010, B0017, Exp Date: 05/31/2026; Lot B0028, B0029, B0030, Exp Date: 06/30/2026; Lot B0052, Exp Date: 07/31/2026; Lot B0091, Exp Date: 09/30/2026
- More code info
- —