123Herbals LLC (123Herbals.com) Issues Voluntary Nationwide Recall of Vail-Bon Jie Yang Wan Capsules Due to the Presence of Undeclared Dexamethasone and Chlorpheniramine

Summary

Company Announcement

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.