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.