Anthony Trinh, 123Herbals LLC has announced a nationwide recall of all lots of Silintan capsules after the U.S. Food and Drug Administration (FDA) found the product contained undeclared meloxicam. Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) that is approved for managing osteoarthritis pain but is not permitted in dietary supplements.
According to the company, "The presence of Meloxicam in Silintan capsules, renders it an unapproved new drug for which the safety and efficacy have not been established and, therefore, subject to recall."
Health risks associated with meloxicam include blood clots, heart attack, stroke, hypersensitivity reactions, gastrointestinal bleeding, ulceration, perforation, and acute kidney injury. These risks are especially concerning for elderly individuals or those taking other medications such as blood thinners or NSAIDs. The company stated: "Exposure to meloxicam at doses exceeding the recommended maximum daily dose of 15mg/day, may result in a reasonable probability of serious life-threatening events such as blood clots, heart attack, and stroke. Patients also face risks of hypersensitivity reactions, gastrointestinal bleeding, ulceration, and perforation, as well as acute kidney injury, particularly in elderly. Dangerous drug-drug interactions may occur in patients on blood thinners or other NSAIDs, significantly increasing bleeding risk." To date, there have been no reports of adverse events related to this recall.
Silintan was sold online nationwide through 123herbals.com and marketed as a dietary supplement for joint and body aches. The affected product comes in 25-count plastic bottles with blue labels and includes all lot numbers within expiry.
Distributors and customers are being notified by email about the recall. The company advises consumers and retailers to stop using Silintan capsules immediately and return them to the place of purchase or discard them. Customers who purchased from the website can return products to 300 West Valley Blvd., P.O. Box 1925, Alhambra CA 91803 for a refund.
For questions regarding the recall or product returns, consumers can contact Anthony Trinh at hello@123herbals.com or call 1-626-656-3202 during business hours.
Adverse reactions or quality issues can be reported to the FDA’s MedWatch Adverse Event Reporting program either online at www.fda.gov/medwatch/report.htm or by mail/fax using forms available at www.fda.gov/MedWatch/getforms.htm.
The company confirmed: "This recall is being conducted with the knowledge of the U.S. Food and Drug Administration."
