Elevated risk U.S. Food and Drug Administration

Vail-Bon Vail-Bon Jie Yang Wan recall: Product is tainted with dexamethasone and chlorpheniramine

Recall published 2+ years ago

Product is tainted with dexamethasone and chlorpheniramine

Vail-Bon Dietary supplements — recalled dietary supplementsVail-Bon Dietary supplements — recalled dietary supplements (photo 2)
2 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Undeclared allergen or ingredient

This is a labelling recall rather than a contamination one: something that must be declared is in the product and is not on the label.

What the notice says: Risk Statement : If used chronically at the recommended dose, dexamethasone could cause severe and serious adverse events such as adrenal suppression (a disorder in which the adrenal glands do not produce enough hormones), central nervous system and psychiatric/behavioral effects, weight gain, gastrointestinal effects, elevated blood glucose, increased infection risks, neuromuscular and skeletal side effects, ocular effects, cardiovascular effects, dermatologic effects endocrine and metabolic issues, among other adverse events not mentioned.

Why it matters: An ingredient that U.S. law requires to be declared is present but missing from the label. People who avoid that ingredient cannot make a safe choice from the packaging.

Symptoms and when to call a doctor

An undeclared allergen is a danger only to people allergic or intolerant to that ingredient. For everyone else the food is safe. Reactions range from an itchy mouth, hives, stomach cramps or vomiting through to anaphylaxis — swelling of the lips, tongue or throat, a tight chest, wheezing, a sudden drop in blood pressure or collapse. If anaphylaxis is suspected, use an epinephrine auto-injector straight away and call 911, even if the symptoms seem to settle, because a second wave can follow hours later.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
September 18, 2024
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Vail-Bon
Product type
Dietary supplements
Distribution
Nationwide
Sold at
Amazon

Products covered by this recall

Vail-Bon Jie Yang Wan

What the company announced

FOR IMMEDIATE RELEASE – Date 09/18/2024 – Rosemead, CA, 123herbals is voluntarily recalling all lots of Vail-Bon Jie Yang Wan capsules to the consumer level. The product has been found to be tainted with the drug ingredients, dexamethasone and chlorpheniramine. Vail Bon Jie Yang Wan capsules is an unapproved new drug for which the safety and efficacy have not been established and, therefore, subject to recall.

Risk Statement : If used chronically at the recommended dose, dexamethasone could cause severe and serious adverse events such as adrenal suppression (a disorder in which the adrenal glands do not produce enough hormones), central nervous system and psychiatric/behavioral effects, weight gain, gastrointestinal effects, elevated blood glucose, increased infection risks, neuromuscular and skeletal side effects, ocular effects, cardiovascular effects, dermatologic effects endocrine and metabolic issues, among other adverse events not mentioned. Depending on the dose and duration of the systemic dexamethasone, these adverse events may be severe and even life threatening. Chlorpheniramine is an antihistamine available in several over the counter products. Inadvertent use of tainted Vail-Bon Jie Yang Wan capsules could lead to a higher than intended chlorpheniramine dose, which could potentially cause overexcitement, loss of coordination, drowsiness, loss of consciousness, and seizures. To date, 123Herbals has not received any reports of adverse events related to this recall.

The product is used to treat skin disease, eczema, itch and is packaged in 30-count plastic bottles . The affected Vail-Bon Jie Yang Wan capsules include all lot numbers and expirations. Vail- Bon Jie Yang Wan capsules were distributed nationwide on 123herbals.com and online retailers including Amazon.

123Herbals is notifying its distributors and customers by emails and is arranging for returns of all recalled products. Consumers and retailers that have Vail- Bon Jie Yang Wan which is being recalled should stop using and/or return to the place of purchase, discard, or contact their doctor .

Consumers with questions regarding this recall can contact 123Herbals by email at [email protected] or via phone at 1-626-656-3202, Monday - Friday 8am-5pm Pacific Time . Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Customers can return their product to the point of purchase for a refund. Customers that bought from the website 123Herbals.com can return to 300 West Valley Blvd. P.O. Box 1925, Alhambra CA 91803. ( Please note only return product to 123Herbals.com if you bought this product from this website, otherwise you will not receive a refund )

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online

Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 1 code you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Package size

Match the net weight or the piece count on the front of the pack.

  • 30 count

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Allergen

Vail-Bon — This is a labelling recall rather than a contamination one: something that must be declared is in the product and is not on the label.

  1. Read the official notice above for the exact ingredient involved, then check whether anyone in your home avoids it.
  2. If nobody here avoids it, the product is safe to eat; the refund is still available if you would rather return it.
  3. If someone does avoid it, stop serving it and check anything already cooked with it.
  4. Warn anyone else who eats from your kitchen, including schools and childminders.

How to get your money back

Food recalls carry a full refund, and in the United States you usually do not need the receipt or the packaging.

  • Take the product, or your photo of the label, to the customer service desk of the store where you bought it. Nearly every national grocer refunds recalled food on the spot.
  • Bought it online? Open the order in your account and use the refund option; marketplace sellers are required to honour a federal recall.
  • If the store refuses, contact the recalling company using the details on this page. The firm, not the shop, carries the cost of a recall.
  • If you have a loyalty card, the retailer can look the purchase up in your history — Kroger, Costco and Walmart all do this routinely.

Remedy named in the notice: Consumers and retailers that have Vail- Bon Jie Yang Wan which is being recalled should stop using and/or return to the place of purchase, discard, or contact their doctor .

Company contact: 123herbals — Consumers: 123Herbals, 1-626-656-3202, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Vail-Bon dietary supplements recalled?

Product is tainted with dexamethasone and chlorpheniramine Risk Statement : If used chronically at the recommended dose, dexamethasone could cause severe and serious adverse events such as adrenal suppression (a disorder in which the adrenal glands do not produce enough hormones), central nervous system and psychiatric/behavioral effects, weight gain, gastrointestinal effects, elevated blood glucose, increased infection risks, neuromuscular and skeletal side effects, ocular effects, cardiovascular effects, dermatologic effects endocrine and metabolic issues, among other adverse events not…

How do I know if I have the recalled product?

The notice does not publish package codes for this recall. Compare the product name, size and the purchase window against the official FDA — Company recall announcements record, and contact the company if you are unsure.

What should I do with it right now?

Read the official notice above for the exact ingredient involved, then check whether anyone in your home avoids it.

Can I get my money back?

The notice says: Consumers and retailers that have Vail- Bon Jie Yang Wan which is being recalled should stop using and/or return to the place of purchase, discard, or contact their doctor .

Where was the recalled product sold?

It was distributed nationwide, including at Amazon.

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