TOPIC: Silintan Capsules by Anthony Trinh, 123Herbals (123HERBALS.COM): Recall - Due to the Presence of Undeclared Meloxicam
AUDIENCE: Consumer, Health Care Professional, Pharmacy, Rheumatology, Cardiology, Gastroenterology
ISSUE: ANTHONY TRINH, 123herbals is recalling all lots of Silintan capsules because FDA analysis has found the product to be tainted with meloxicam. Meloxicam, is an approved Nonsteroidal Anti-Inflammatory Drug, (NSAID) indicated for management of osteoarthritis pain. Products containing meloxicam cannot be marketed as dietary supplements. 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.
Risk Statement: 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, Anthony Trinh, 123Herbals has not received any reports of adverse events related to this recall.
Silintan capsules were distributed nationwide online at 123herbals.com
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: The tainted Silintan is marketed as a dietary supplement for relief of joint and body aches.
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 Silintan capsules, which is being recalled, should stop using this product 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 Anthony Trinh, 123Herbals LLC by email at hello@123herbals.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. Customers that bought from the website 123Herbals.com can return to 300 West Valley Blvd. P.O. Box 1925, Alhambra CA 91803.
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