← FDA ENFORCEMENT
D-0430-2025Class II

KENIL HEALTHCARE PRIVATE LIMITED

Recalling firm
KENIL HEALTHCARE PRIVATE LIMITED
Product type
Drug
Status
Terminated
Report date
2025-05-28
Distribution
DE and NC
Firm state
N/A
Product quantity
383,904 Tubes
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
Reason for recall

CGMP Deviations

Product description

Cinnafresh anticavity gel toothpaste, sodium fluoride 0.22%, Bold Cinnamon Flavor, NET WT. 0.85 OZ (24 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-133-01

Code / lot info

Lot B0011, B0012, Exp Date: 05/31/2026; Lot B0070, B0074, Exp Date: 08/31/2026; Lot B0075, B0077, B0078, B0079, B0080, B0081, B0082, B0083, B0084, B0085, Exp Date: 09/30/2026

Other recalls SPEQ maps to Risk Management & CAPA
2026-07-22Class IAbiomed, Inc.2026-07-22Class IAbiomed, Inc.2026-07-22Class IAbiomed, Inc.2026-07-22Class IAbiomed, Inc.
See all Risk Management & CAPA recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.