123Herbals LLC has issued a nationwide recall of all lots of Vail-Bon Jie Yang Wan supplement capsules due to the presence of undeclared drugs – dexamethasone and chlorpheniramine.
The U.S. Food and Drug Administration says Vail Bon Jie Yang Wan is an unapproved new drug for which the safety and efficacy have not been established and, therefore, subject to recall.
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.
What to do
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 123Herbals@gmail.com 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.