Class 2 medicines recall: Asda, St John’s Wort, HRI Good Mood and Superdrug St John’s Wort tablets THR 02231/0002

Action within 48 hours: patient, pharmacy and retail level recall of St John's Wort tablets. Testing has shown the presence of a toxic pyrrolizidine alkaloid (PA) above the threshold recommended by the Committee on Herbal Medicinal Products (HMPC).

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

Brief description of the problem

The Herbal Research Company Ltd is recalling six batches of St John’s Wort tablets as testing has shown the presence of a toxic pyrrolizidine alkaloid (PA) above the threshold recommended by the Committee on Herbal Medicinal Products (HMPC).

Retailers and Wholesalers are asked to return any remaining stock to their original supplier.

Advice for healthcare professionals and patients

If you still have any of the St John’s Wort Tablets left, you should return them to the Herbal Research Company Ltd. Pyrrolizidine alkaloids (PAs) are known to cause liver problems. Symptoms of liver disorders can be delayed following exposure, but include yellowing of the whites of the eyes and/or skin, nausea, vomiting, dark urine, abdominal pain and unusual tiredness. Such symptoms may not occur until days or weeks after exposure to PAs. If you are experiencing any of these symptoms you should tell your doctor straightaway. If you experience any other side-effects, or have any questions or concerns about your health, speak to your doctor, pharmacist, or other healthcare professional. Any suspected side effects can be reported to MHRA through our medicines safety monitoring system, the Yellow Card Scheme or download the Yellow Card App here.

Patients

Patients should return any packs to The Herbal Research Company Ltd.

Telephone: 01934 838820

E-mail: recall@QP-Services.com to receive a pre-paid stamped addressed envelope.

For medical information enquiries please contact:

The Herbal Research Company Ltd.

Telephone: 01934 838820 or 07919585040

Email: recall@QP-Services.com

QP-Services UK Ltd
46 High Street
Yatton BS49 4HJ
UK

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Class 2 medicines recall: Asda, St John’s Wort, HRI Good Mood and Superdrug St John’s Wort tablets THR 02231/0002

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. As this is a General Sales List Traditional Herbal Registration product, there is low likelihood that it will be relevant to hospital pharmacies. Local area teams are asked to forward this to community pharmacists for action, and to general practitioners for information.

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