Products found to contain undeclared medicines
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| The United States: Buy-herbal.com issues voluntary nationwide recall of Nhan Sam Tuyet Lien Truy Phong Hoan Capsules due to undeclared furosemide, dexamethasone and chlorpheniramine |
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The United States Food and Drug Administration (FDA) announces that 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.
Nhan Sam Tuyet Lien Truy Phong Hoan Capsules 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.
Chlorpheniramine is an antihistamine used for allergies. 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.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/buy-herbalcom-issues-voluntary-nationwide-recall-nhan-sam-tuyet-lien-truy-phong-hoan-capsules-due
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by the Therapeutic Goods Administration and FDA, and was posted on the Drug Office website on 4 Feb 2022 and 2 Nov 2024 respectively.
Ends/Saturday, Dec 14, 2024
Issued at HKT 12:00
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