Voluntary recall of Viridian Nutrition Black Cohosh Root capsules

All herbal safety warnings and alerts

23 November 2012

In response to an urgent notice issued by the Medicines and Healthcare products Regulatory Agency (MHRA), Viridian Nutrition has agreed to recall stocks of Black Cohosh Root capsules, as some batches of the product have been found to contain an undeclared plant species in addition to the declared plant species. Consumers are advised to stop using the products and return unused product to Viridian Nutrition (or health food stores).

Reason for warning
The product is labelled as containing Black Cohosh, which is the common name of Cimicifuga racemosa,  as specified in the European, British and American Pharmacopoeia. However tests carried out on the product have shown that the product also contains other Cimicifuga species, probably Cimicifuga foetida.

The MHRA has asked for Viridian Nutrition Black Cohosh Root capsules to be recalled from the market. It appears that this Black Cohosh extract may also be used in other unlicensed medicines. The Agency is investigating to ascertain which products may be affected.

Safety concerns
The undeclared plant, Cimicifuga foetida, is not used in Western herbal medicine and its properties or safety have not been evaluated. The Agency therefore considers that the inclusion of extracts from this undeclared plant species means that the product is not of the nature or quality required by the purchaser.

Recent issues
The MHRA issued a press release last month following a serious case of liver failure resulting in a liver transplant suspected to have been caused by a herbal product containing Black Cohosh. Black Cohosh is commonly used to relieve menopausal symptoms but has been associated with the risk of liver problems.  Since 2006, the MHRA has asked all manufacturers of Black Cohosh products to ensure that an appropriate warning about possible liver problems is included on the label.

The MHRA always recommends that registered herbal products are used. Registered products can be identified by the Traditional Herbal Registration (THR) registration number or logo on their packaging. These products have been assessed and quality checked to ensure that they are acceptably safe to use and are accompanied by a leaflet with information on how to use the product with possible side effects listed. The unlicensed products do not have the THR registration or logo number and have not been assessed for quality.

Further information on safety can be found in the patient information leaflets included with the Public Assessment Reports.

Herbal practitioners who make up preparations for their individual patients should seek confirmation from suppliers that authentic plant materials have been used in the preparation of any Black Cohosh ingredients.

The MHRA is currently investigating a number of complaints about herbal products being marketed without the necessary authorisation and will continue to take regulatory action to protect the public. In the meantime, should anyone have taken these products or have any concerns they should seek the advice of their GP. Please report any suspected adverse reactions through the Yellow Card Scheme.

Press release: People asked to return Black Cohosh Root capsules made by Viridian Nutrition

Page last modified: 27 November 2012