Status
Ongoing
Drug Enforcement D-0434-2025
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 1.5 OZ (43 g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-04
- Product quantity
- 216,720 Tubes
- 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-0434-2025
- Event ID
- 96797
- Recall initiation date
- April 24, 2025
- Center classification date
- May 19, 2025
- Code info
- Lot B0013, Exp Date: 05/31/2026; Lot B0018, Exp Date: 06/30/2026; Lot B0053, B0054, Exp Date: 07/31/2026; Lot B0090, B0091, B0092, B0093, B0094, B0095, B0096, B0097, B0098, B0099, B0100, B0101, Exp Date: 09/30/2026
- More code info
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