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FDA Advises Patients Not to Use Herbal Doctor Remedies’ Medicines

Audience: Patients

July 23, 2019 -- FDA advises patients not to use any drugs manufactured by Herbal Doctor Remedies, Monterey Park, California, because these drugs were made under poor conditions.

Herbal Doctor Remedies manufacturers a variety of unapproved new drugs, including Brain Forte, New Life, Lump Shrinker, Asma-F, Herpes-P, Anemia Off, Bone Fixer and Tumor Shrinker offered on several websites. FDA recommends patients stop using these drugs and dispose of them.

During FDA’s recent inspection of the Herbal Doctor Remedies’ facility, investigators observed insanitary conditions and numerous serious violations of current good manufacturing practices (CGMP). Herbal Doctor Remedies cannot assure the quality or safety of its products due to the poor conditions and manufacturing practices at the facility. On July 11, 2019, FDA recommended that Herbal Doctor Remedies recall all unexpired drugs. Herbal Doctor Remedies initially agreed to recall; however, the company has not taken action to remove these potentially dangerous drugs from the market.

To date, FDA is not aware of any reports of adverse events associated with medicines manufactured by Herbal Doctor Remedies. Patients who use Herbal Doctor Remedies’ medicines and have concerns should contact their health care professional.

FDA issued a warning letter to Herbal Doctor Remedies in 2017 for marketing unapproved and misbranded drugs. Using drugs with unsubstantiated claims may prevent patients from seeking FDA-approved treatments that have been demonstrated to be safe and effective.

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 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.

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.

FDA encourages health care professionals and patients to report adverse events or quality problems experienced with the use of any medication to FDA’s MedWatch Adverse Event Reporting program:

Complete and submit the report online; or
Download and complete the form, then submit it via fax at 1-800-FDA-0178.

Source: FDA

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