FDA ANNOUNCEMENT
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:
- FDA Publish Date:
- Product Type:
- Drugs
- Reason for Announcement:
-
Recall Reason DescriptionAll 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 DescriptionDrug 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.