September 2024 FDA Recall Drug by 123herbals
D-0008-2025 - Marketed without an approved NDA/ANDA

This Class I drug recall was voluntarily initiated by 123herbals on September 18, 2024 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed in Distributed via Amazon and 123Herbals.com website and the recall is currently ongoing.

Recall Number: D-0008-2025

Reason for Recall
Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine.
Initiated
09-18-2024
Reported
10-16-2024
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95391
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
123Herbals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed via Amazon and 123Herbals.com website
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# All lots within expiry