Drug & medication recalls High risk

Vail-Bon Jie Yang Wan capsules recalled over undeclared dexamethasone

Recall date
September 18, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
123Herbals recalls Vail-Bon Jie Yang Wan capsules, 30-count bottle, Vall Boon Medical Factory Sdn. Bhd., No 1, Lorong Mengkudu, Taman Meng…
Recall number
D-0008-2025
FDA classification
Class I
Brand / firm
123Herbals
Sold / distributed
Distributed via Amazon and 123Herbals.com website

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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

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