Herbal Doctor Remedies Issues Voluntary Nationwide Recall of All Drug Products Due to Marketing Without FDA Approval and Concerns with Manufacturing Practices

FDA ANNOUNCEMENT

Summary

• Company Announcement Date: July 24, 2019
• FDA Publish Date: July 24, 2019
• Product Type: Drugs
• Reason for Announcement: All products have been marketed without FDA approval and were manufactured outside of the controls required by current Good Manufacturing Practices (cGMP)
• Company Name: Herbal Doctor Remedies
• Brand Name: Herbal Doctor Remedies
• Product Description: Drug products

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FDA Announcement

Herbal Doctor Remedies is voluntarily recalling all drug products (see table below) 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).

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.

Product Name	Dosage Form
Anemia Off	Capsules
Appetrol	Capsules
Asma Aid	Capsules
“Asma” Stopper	Capsules
Asthma Balm	Ointment
Awake	Capsules
Baby Saver	Capsules
Bone Fixer	Capsules
Cardia Forte	Capsules
Deafness Off	Capsules
Detensin	Capsules
Dragon Pain Balm	Ointment
Dragon Pain Oil	Massage Oil
Edema Off	Capsules
Fungo Balm	Ointment
Fungo Off	Capsules
Glauco-Catar	Capsules
Hair Back	Capsules
Herpes-G	Capsules
Herpes-P	Capsules
Herpes-S	Capsules
Herpes-V Balm	Ointment
Lipidtrol	Capsules
Lube Lax	Capsules
Lump Off	Capsules
Lung Fixer	Capsules
Lung Saver	Capsules
Lung Tonic EX	Capsules
Mental Tonic	Capsules
Migraine Off	Capsules
Pain Away	Capsules
Pain Stopper	Capsules
Prostatin	Capsules
Psoriasis Balm	Ointment
Smoke End	Capsules
Sperm Booster	Capsules
Stomach Flu	Capsules
Stone Purger	Capsules
Thyro-H	Capsules
Thyro-Lo	Capsules
Vertigo Off	Capsules
Worm Off	Capsules
Yeast Douche Powder	Powder

 

The products were marketed and distributed Nationwide via online sales through the following websites: www.herb-doc.com, www.theraherb.com, www.herbaldoctorremedies.com, www.chinasecretremedy.com, www.theraherb.ecrater.com. Products may also have been purchased through acupuncturists or other alternative medicine providers.

Herbal Doctor Remedies is notifying its customers by public press release and is arranging for return of all recalled products. Consumers who have product which is being recalled should stop using and return to Herbal Doctor Remedies 497 Cumbre St, Monterey Park, CA 91754 or place of purchase.

Consumers with questions regarding this recall can contact Herbal Doctor Remedies by phone number 626-999-4702 or herbdoc30@gmail.com, Monday through Friday from 9 am to 5 pm, Pacific Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.

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.

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FDA Contact Information

• Consumers: 626-999-4702; herbdoc30@gmail.com