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Recall Observatory FDA recall evidence

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.

D-0008-2025

September 18, 2024

Class I

Product summary

Firm
123Herbals
Event
Event 95391
Status
Ongoing
Classification
Class I
Quantity
unknown
Official record key
drug-enforcement:D-0008-2025

Official wording

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

Code information: All lots within expiry

Distribution pattern: Distributed via Amazon and 123Herbals.com website

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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