FDA recall D-0008-2025

123Herbals · Class I · drug

Product

Vail-Bon Jie Yang Wan capsules, 30-count bottle, Vall Boon Medical Factory Sdn. Bhd., No 1, Lorong Mengkudu, Taman Mengkudu, 14100 Juru, Malaysia.

Reason for recall

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

Distribution

Distributed via Amazon and 123Herbals.com website

Key facts

Status
Ongoing
Initiation date
2024-09-18
Report date
2024-10-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Rosemead, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0008-2025