April 17, 2024

Herbal Doctor Remedies Recalls Products Marketed Without FDA Approval

Herbal Doctor Remedies is voluntarily recalling all drug products within expiration dates to the consumer level. These products were marketed without FDA approval and were manufactured outside controls required by current Good Manufacturing Practices.

Herbal Doctor Remedies Recalls Products Marketed Without FDA Approval

This could result in risk to consumers, since they are marketed with uses that are not amenable to self-diagnosis. And, lack of controls in the manufacturing of these products do not provide assurance of quality. No reports of adverse reactions have been received to date by the company.

These products are intended to be used as Chinese Herbal Medicines, marketed for treatment of diseases in people which the FDA has found makes them unapproved new drugs.

These recalled Herbal Doctor products are packaged in white plastic containers with screw-on lids Each container has a Herbal Doctor Remedies Brand white stick-on label and red, green, and blue writing with a product expiration date. There is no lot number on these products. The recall affects all the Herbal Doctor Remedies brand products and quantities within a 3-year expiration date.

You can see the long list of recalled product names on the FDA web site. Some of them are Anemia Off, Asthma Balm, Baby Saver, Bone Fixer, Cardia Forte, Edema Off, Fungo Off, Herpes-P, Lump Off, Lung Fixer, Pain Stopper, Smoke End, and Worm Off, among others. They were distributed and marketed through four specific websites, and may also have been sold through acupuncturist or alternative medicine providers.

If you purchased any of these items, do not use them. Return them to the place of purchase, or ask in your community where you should dispose of drugs.

If you have experienced an adverse reaction while using one of these products, report it to the FDA’s MedWatch Adverse Event Reporting program, either through fax or regular mail, or by submitting a report online.

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