Elevated risk U.S. Food and Drug Administration

Buy-herbal.com Nhan Sam Tuyet Lien Truy Phong Hoan dietary supplement capsules recall: Device & Drug Safety – Unapproved Drug

Recall published 1+ years ago

Device & Drug Safety – Unapproved Drug

Buy-herbal.com Prescription & OTC drugs — recalled prescription & otc drugsBuy-herbal.com Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)Buy-herbal.com Prescription & OTC drugs — recalled prescription & otc drugs (photo 3)
3 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Undeclared allergen or ingredient

An ingredient subject to mandatory disclosure was left off the packaging, which is what the agency classes as misbranding.

What the notice says: 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.

Why it matters: An ingredient that U.S. law requires to be declared is present but missing from the label. People who avoid that ingredient cannot make a safe choice from the packaging.

Symptoms and when to call a doctor

An undeclared allergen is a danger only to people allergic or intolerant to that ingredient. For everyone else the food is safe. Reactions range from an itchy mouth, hives, stomach cramps or vomiting through to anaphylaxis — swelling of the lips, tongue or throat, a tight chest, wheezing, a sudden drop in blood pressure or collapse. If anaphylaxis is suspected, use an epinephrine auto-injector straight away and call 911, even if the symptoms seem to settle, because a second wave can follow hours later.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
December 12, 2024
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Buy-herbal.com
Product type
Prescription & OTC drugs

Products covered by this recall

Nhan Sam Tuyet Lien Truy Phong Hoan dietary supplement capsules

What the company announced

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 [email protected] for return and refund. Please ship the recalled products to 136-61 41st Ave, Box # 248, Flushing, NY 11355 and contact [email protected] for refunds.

Consumers with questions regarding this recall can email [email protected] 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 [email protected] 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.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 5 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Package size

Match the net weight or the piece count on the front of the pack.

  • 5.24 mg
  • 1.84 mg
  • 2.22 mg
  • 4.38 mg
  • 1.54 mg

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Allergen

Buy-herbal.com — An ingredient subject to mandatory disclosure was left off the packaging, which is what the agency classes as misbranding.

  1. Read the official notice above for the exact ingredient involved, then check whether anyone in your home avoids it.
  2. Warn anyone else who eats from your kitchen, including schools and childminders.
  3. Report any reaction to the FDA so it is recorded against this recall.
  4. If nobody here avoids it, the product is safe to eat; the refund is still available if you would rather return it.

Refunds, and what else you can claim

The purchase price is the floor, not the ceiling. Where a recall caused you a real cost, say so.

  • Claim the refund at the store first; it is the fastest route and needs the least paperwork.
  • If you bought several packs over time, list them. Firms routinely settle for more than a single unit when a customer asks.
  • Medical costs, lost earnings or a spoiled event are not handled at the service desk. Write to the company contact on this page instead, with dates and documents.
  • Keep copies of everything you send. If a recall caused harm, that file is what any later claim rests on.

Remedy named in the notice: 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.

Company contact: Buy-herbal.com — Consumers: 917-495-6088, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Buy-herbal.com prescription & otc drugs recalled?

Device & Drug Safety – Unapproved Drug 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.

How do I know if I have the recalled product?

The notice does not publish package codes for this recall. Compare the product name, size and the purchase window against the official FDA — Company recall announcements record, and contact the company if you are unsure.

What should I do with it right now?

Read the official notice above for the exact ingredient involved, then check whether anyone in your home avoids it.

Can I get my money back?

The notice says: 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.

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