Recall notice
Silintan Ache Relief Capsules recalled due to Undeclared Meloxicam, USA
5 days ago •source fda.gov
United States
ANTHONY TRINH, 123herbals LLC is voluntarily recalling all lots of Silintan capsules to the consumer level. 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. Silintan capsules were distributed nationwide online at the 123herbals website in the United States.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 LLC has not received any reports of adverse events related to this recall.
The tainted Silintan is marketed as a dietary supplement for relief of joint and body aches and is packaged in 25-count plastic bottles with blue labels (see labels below). The affected Silintan capsules include all lot numbers within expiry.
Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/anthony-trinh-123herbals-llc-123herbalscom-issues-nationwide-recall-silintan-capsules-due-presence
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