Vail-Bon Jie Yang Wan capsules, 30-count bottle, Vall Boon Medical Factory Sdn. Bhd., No 1, Lorong Mengkudu, Taman Mengk
Summary
The FDA issued a Class I for Vail-Bon Jie Yang Wan capsules, 30-count bottle, Vall Boon Medical Factory Sdn. by 123Herbals. Reason: Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine..
Details
Source
Drug Recall
External ID
D-0008-2025
Action Date
2024-10-16
Status
Ongoing
Category
drug
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.
Lot/Code Info: All lots within expiry
Quantity Affected: unknown
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
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-18
Company
Rosemead, CA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 29 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (123Herbals) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does 123Herbals have FDA actions?
This is the only FDA action we have on record for 123Herbals in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0008-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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