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FDA ANNOUNCEMENT

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

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

Summary

Company Announcement Date:
July 24, 2019
FDA Publish Date:
July 24, 2019
Product Type:
Drugs
Reason for Announcement:
Recall Reason Description
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:
Brand Name(s)
Herbal Doctor Remedies
Product Description:
Product Description
Drug products

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.


FDA Contact Information

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