Medicine recalls
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| The United States: Herbal Doctor Remedies issues voluntary nationwide recall of all drug products due to marketing without FDA approval and concerns with manufacturing practices |
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The US Food and Drug Administration (FDA) announces that Herbal Doctor Remedies is voluntarily recalling all drug products within expiry to the consumer level. These products have been marketed without FDA approval and were manufactured outside of the controls required by current Good Manufacturing Practices (cGMP). Please refer to the website in FDA for details of the affected products.
These products could potentially result in risk to consumers as they are marketed with intended uses not amendable to self-diagnosis. In addition, lack of controls in the manufacture of the products do not provide assurances of finished product quality. To date, Herbal Doctor Remedies has not received any reports of adverse events related to this recall.
These products are intended to be used as Chinese Herbal Medicines marketed for treatment of disease conditions in humans which the FDA has determined may constitute unapproved new drugs. They are packaged in white plastic containers with screw-on lids. Each container is identified with an Herbal Doctor Remedies Brand white stick-on label and red, green, and blue writing with a product expiry. Products are not identified with a lot number. This recall includes all the Herbal Doctor Remedies brand products and quantities within the labeled 3-year expiry. The products were marketed and distributed nationwide via online sales through various websites. Products may also have been purchased through acupuncturists or other alternative medicine providers.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/herbal-doctor-remedies-issues-voluntary-nationwide-recall-all-drug-products-due-marketing-without
In Hong Kong, the above products are not registered pharmaceutical products. There is also no registered pharmaceutical product manufactured by the above company. Related news was previously issued by FDA, and was posted on the Drug Office website on 24 Jul 2019.
Ends/Thursday, Jul 25, 2019
Issued at HKT 16:00
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