Drug Enforcement D-0421-2025

CGMP Deviations

Status

Ongoing

Classification

Class II

Report Date

May 28, 2025

Termination Date

Product Information

Product description
Artridon Glucosamine (menthol 2% and Methyl Salicylate 15% - Topical Analgesic), for arthritis joint pain relief, 5 oz (142g) Tube, Dist by/por: Pharmadel LLC, New Castle, DE, 19720, Made in India, NDC 55758-030-05, UPC 8 10096 77151 3.
Product quantity
9,984 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-0421-2025
Event ID
96797
Recall initiation date
April 24, 2025
Center classification date
May 19, 2025
Code info
Lot SP25A, Exp Date: 09/30/2026
More code info