Medicine recalls
|
| |
| The United States: 123Herbals LLC (123Herbals.com) Issues Voluntary Nationwide Recall of Vail-Bon Jie Yang Wan Capsules Due to the Presence of Undeclared Dexamethasone and Chlorpheniramine |
| |
The United States Food and Drug Administration (FDA) announces that 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.
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.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/123herbals-llc-123herbalscom-issues-voluntary-nationwide-recall-vail-bon-jie-yang-wan-capsules-due
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by FDA, and was posted on the Drug Office website on 11 Jul 2024.
Ends/Saturday, Sep 21, 2024
Issued at HKT 12:00
|
| |
|
