Product information

 

EL number

EL(16)A/01

 

MDR number

013-01/16

 

THR number

02231/0002

 

Company name

St John’s Wort

 

Product description

 

Product Name Batch Number Expiry Date Pack Size First distributed
Asda St John’s Wort 14279 05/2016 30 tablets 25/10/2013
HRI Good Mood 14255 05/2016 30 tablets 26/09/2013
HRI Good Mood 14662 05/2016 30 tablets 09/04/2014
HRI Good Mood 14498 08/2016 30 tablets 16/01/2014
HRI Good Mood 14660 08/2016 30 tablets 11/05/2014
Superdrug St John’s Wort 14523 08/2016 30 tablets 08/01/2014

 

The above batches of Asda St John’s Wort, HRI Good Mood and Superdrug St John’s Wort tablets are being recalled by The Herbal Research Company Ltd. This is because during testing, a trace of a toxic pyrrolizidine alkaloid above the recommended limit, set by Committee on the Herbal Medicinal Products (HMPC), was found.

Pharmacists should return the affected batches to their original wholesaler. Patients should return any affected batches to The Herbal Research Company Ltd. Patients can email recall@QP-Services.com to receive a pre-paid stamped addressed envelope in order for them to send them back.

Pyrrolizidine alkaloids can cause liver disorders. Healthcare professionals should refer patients immediately if they present liver disorder symptoms and have been taking the affected St John’s wort products. Patients are also advised to speak their doctor or pharmacist if they are suffering from any other side effects. Suspected side effects can be reported to the Medicines and Healthcare products Regulatory Agency (MHRA) via the Yellow Card Scheme or via the Yellow Card app.

For medical information enquiries, pharmacies can contact The Herbal Research Company Ltd by telephone on 01934 838820 or 07919 585040 or via email recall@QP-Services.com. More information can be found on the MHRA) section on the GOV.UK website.