COMPANY ANNOUNCEMENT
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
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- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Drugs
- Reason for Announcement:
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Recall Reason Description
Device & Drug Safety – Unapproved Drug
- Company Name:
- Buy-herbal.com
- Brand Name:
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Brand Name(s)
- Product Description:
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Product Description
Nhan Sam Tuyet Lien Truy Phong Hoan dietary supplement capsules
Company Announcement
FOR IMMEDIATE RELEASE 12th December 2024, Flushing, New York, Buy-herbal.com is voluntarily recalling all lots within expiry of Nhan Sam Tuyet Lien Truy Phong Hoan Capsules to the consumer level. FDA analysis has found these products to contain undeclared Furosemide, Dexamethasone and Chlorpheniramine. Furosemide was found at 5.24 mg/g or 1.84 mg/capsule. Dexamethasone was found at 2.22 mg/g or 0.780 mg/capsule. Chlorpheniramine was found at 4.38 mg/g or 1.54 mg/capsule. Products containing Furosemide, Dexamethasone and Chlorpheniramine cannot be marketed as dietary supplements. Nhan Sam Tuyet Lien Truy Phong Hoan Capsules is an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.
Risk Statement: Chlorpheniramine is an antihistamine available in several over the counter products. Inadvertent consumption of chlorpheniramine could lead to a higher than intended dose, which could potentially cause overexcitement, loss of coordination, drowsiness, loss of consciousness, and seizures. Dexamethasone is a corticosteroid commonly used to treat inflammatory conditions. Corticosteroid use can impair a person’s ability to fight infections and can cause high blood sugar levels, muscle injuries and psychiatric problems. When corticosteroids are taken for a prolonged period, or at high doses, they can suppress the adrenal gland. Abrupt discontinuation can cause withdrawal symptoms. In addition, the undeclared dexamethasone may cause serious side effects when combined with other medications. Furosemide is a potent diuretic used to treat conditions such as, congestive heart failure, high blood pressure, and edema. It can cause dizziness, sudden drop in blood pressure when standing up from a seated or lying position, hearing loss, kidney damage, and profound dehydration and electrolyte imbalance. Patients allergic to sulfonamides may also be allergic to furosemide. Buy-herbal.com has not received any reports of adverse events related to this recall.
This is marketed as a dietary supplement for treatment for lumbago gout, arthrodynia, myasthenia, limb numbness, pain induced by acclimation fever and rheumatism, osteocope and arthritis. The product is packaged in bottle containing 30 capsules each. The affected Nhan Sam Tuyet Lien Truy Phong Hoan include all batches within Expiration dates.
Buy-herbal.com is notifying its customers via email who have bought the product on buy-herbal.com to return for a refund of the recalled product. Consumers that have Nhan Sam Tuyet Lien Truy Phong Hoan which is being recalled should stop using and contact info@buy-herbal.com for return and refund. Please ship the recalled products to 136-61 41st Ave, Box # 248, Flushing, NY 11355 and contact info@buy-herbal.com for refunds.
Consumers with questions regarding this recall can email info@buy-herbal.com or call 917 495 6088 on Monday through Friday from 10am till 6pm of the week Eastern Time. 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. Customers can contact info@buy-herbal.com for return and refunds.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
