TOPIC: Vail-Bon Jie Yang Wan Capsules By 123Herbals (123Herbals.com): Recall - Due to the Presence of Undeclared Dexamethasone and Chlorpheniramine
AUDIENCE: Consumer, Health Professional, Pharmacy, Dermatology
ISSUE: 123herbals is recalling all lots of Vail-Bon Jie Yang Wan capsules because 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.
Vail- Bon Jie Yang Wan capsules were distributed nationwide on 123herbals.com and online retailers including Amazon.
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.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: The product being recalled is used to treat skin disease, eczema, itch.
RECOMMENDATIONS:
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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.
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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.
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Consumers with questions regarding this recall can contact 123Herbals by email at 123Herbals@gmail.com or via phone at 1-626-656-3202.
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Consumers can return their product to the point of purchase for a refund. Consumers 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).
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