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Recall notice

Buy-herbal.com Dietary Supplement Capsules - recalled due to unapproved drug, USA

1 year ago source fda.gov

United States

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.

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.

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.

Consumers that have Nhan Sam Tuyet Lien Truy Phong Hoan which is being recalled should stop using and contact Buy Herbal for return and refund.

Company name: Buy-herbal.com
Brand name: Buy-herbal.com
Product recalled: Nhan Sam Tuyet Lien Truy Phong Hoan dietary supplement capsules
Reason of the recall: Device & Drug Safety – Unapproved Drug
FDA Recall date: December 13, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/buy-herbalcom-issues-voluntary-nationwide-recall-nhan-sam-tuyet-lien-truy-phong-hoan-capsules-due

#drugs #recall #unitedstates

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