D-0008-2025 Class I Ongoing
FDA drug recall D-0008-2025 was initiated by 123Herbals on September 18, 2024 and is designated Class I. Reason for recall: Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine. The recall status is ongoing. Affected quantity: unknown.
Recall Details
- Product Type
- Drugs
- Report Date
- October 16, 2024
- Initiation Date
- September 18, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- unknown
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.
Reason for Recall
Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine.
Distribution Pattern
Distributed via Amazon and 123Herbals.com website
Code Information
All lots within expiry