Vail-Bon Jie Yang Wan capsules recalled for undeclared pharmaceutical ingredients
Vail-Bon Jie Yang Wan capsules have been recalled for containing undeclared dexamethasone and chlorpheniramine. The product was marketed without FDA approval.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA has classified this as a Class I recall. Per regulatory criteria, FDA Class I recalls must receive a severity score of at least 4. The product is an unapproved medication containing undeclared active pharmaceutical ingredients that present serious potential for adverse health consequences.
Plain-English summary
Vail-Bon Jie Yang Wan capsules (30-count bottles) manufactured by Vall Boon Medical Factory Sdn. Bhd. and distributed by 123Herbals are being recalled due to FDA Class I violation. The product was marketed without required FDA approval (NDA/ANDA) and contains undeclared active pharmaceutical ingredients: dexamethasone, a corticosteroid, and chlorpheniramine, an antihistamine.
These active ingredients pose serious health risks when taken without medical supervision or knowledge of their presence. Taking undeclared pharmaceuticals, particularly without awareness of their interactions with other medications or individual health conditions, can result in serious adverse effects.
The product was distributed through Amazon and the 123Herbals.com website. All lots currently in distribution are within their stated expiry dates.
Consumers who have purchased this product should discontinue use immediately. Anyone who has taken these capsules should contact their healthcare provider, particularly if they are taking other medications or have underlying health conditions.
The recalled product
- 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.
- Manufacturer
- 123Herbals
- Category
- Drug
- Hazard
- undeclared-drugs
- unapproved-medication
- dexamethasone
- chlorpheniramine
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots within expiry
Distribution
Distribution scope not specified by the agency.
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