Drug Enforcement D-0008-2025

Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine.

Status

Ongoing

Classification

Class I

Report Date

October 16, 2024

Termination Date

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Product Information

Product description
Vail-Bon Jie Yang Wan capsules, 30-count bottle, Vall Boon Medical Factory Sdn. Bhd., No 1, Lorong Mengkudu, Taman Mengkudu, 14100 Juru, Malaysia.
Product quantity
unknown
Reason for recall
Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine.
Recall initiation reason
—
Initial firm notification
E-Mail
Distribution pattern
Distributed via Amazon and 123Herbals.com website

Location & Firm

Recalling firm
123Herbals
Address
7214 Berne St

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0008-2025
Event ID
95391
Recall initiation date
September 18, 2024
Center classification date
October 10, 2024
Code info
All lots within expiry
More code info
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