CLEVELAND, Ohio – Silintan capsules, a dietary supplement tainted with an anti-inflammatory drug, have been recalled, according to the Food and Drug Administration.
The capsules were distributed nationwide at 123herbals.com. The tainted Silintan is packaged in 25-count plastic bottles with blue labels. The affected capsules include all lot numbers.
Silintan is marketed as a dietary supplement for relief of joint and body aches. Anthony Trinh, 123herbals LLC is voluntarily recalling all lots of the capsules after FDA analysis found the product to be tainted with meloxicam.
Meloxicam is an approved nonsteroidal anti-inflammatory drug intended 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, according to the FDA, and since its safety has not been established it is subject to recall.
Exposure to meloxicam at doses exceeding the recommended maximum daily dose of 15mg per day may result in life-threatening conditions such as blood clots, heart attack and stroke. Risks include hypersensitivity reactions, gastrointestinal bleeding, ulceration and acute kidney injury, particularly in the elderly.
Dangerous drug-drug interactions may occur in patients on blood thinners or other NSAIDs.
Consumers and retailers that have silintan capsules should stop using the product immediately. They can return it to the place of purchase for a refund or discard it. Customers who bought it via 123Herbals.com can return it to 300 West Valley Blvd., P.O. Box 1925, Alhambra, Calif. 91803.
Consumers should contact their physician or healthcare provider if they have experienced problems that may be related to using the product.
More info
• Contact Anthony Trinh, 123Herbals LLC at [email protected] or 626-656-3202 from 11 a.m. to 8 p.m. Monday to Friday. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program online, by mail or fax. Complete and submit the report at fda.gov/medwatch/report.htm, download the form at fda.gov/MedWatch/getforms.htm or call 800-332-1088 to request a reporting form.
• For details on recalls and food-safety questions, call the USDA meat and poultry hotline, 888-674-6854 or chat via Ask USDA 10 a.m. to 6 p.m. weekdays. Consumers can email questions to [email protected]. For those who need to report a problem with a meat, poultry or egg product, the electronic consumer-complaint monitoring system is online. Recalls are posted online.
