My HPRA: Register

UK recall of three products containing St. John’s Wort

Notice type: Warning

Date: 08/02/2016

 This alert is for information and relates to three products marketed in the UK containing St. John’s Wort:

• Asda St John’s Wort Tablets
• HRI Good Mood Tablets
• Superdrug St John’s Wort Tablets

Problem Or Issue:
The HPRA has been made aware of a precautionary patient level recall that is currently taking place in the UK relating to specific batches of the above three medicines. The batches are being recalled due to a contamination issue.

There is no indication that any of the products subject to the UK recall action have been placed on the Irish market through any regulated supply route.

Tablets from the impacted batches were found to contain levels of a toxic pyrrolizidine alkaloid (PA) above the threshold recommended by the Committee on Herbal Medicinal Products (HMPC), a European expert body. Further information pertaining to the precautionary UK recall may be found at MHRA St. Johns Wort UK Drug Alert and MHRA St. Johns Wort UK Press Statement.

The UK recall involves the following batches of products:
                                    

Product Name

Batch No.

Expiry Date

Asda St John’s Wort Tablets

14279

05/2016

HRI Good Mood Tablets

14255

05/2016

HRI Good Mood Tablets

14662

05/2016

HRI Good Mood Tablets

14498

08/2016

HRI Good Mood Tablets

14660

08/2016

Superdrug St John’s Wort Tablets

14523

08/2016

The HPRA confirms that none of these UK products is authorised or registered for sale and supply to the Irish market.

However, the HPRA is aware of the potential for Irish consumers or patients to purchase St. John’s Wort-containing products from Northern Ireland and other parts of the UK. Therefore, the HPRA wishes to make consumers and patients aware of the recall in the UK of these batches of the above three products in order that they can ascertain if they have in their possession packs from any of the impacted batches.

Actions To Be Taken:
If any patient or member of the public has packs of the above-referenced UK batches, they are advised to immediately stop using the product and to consult their pharmacist or doctor. When consulting their pharmacist or doctor, patients may find it useful to take a copy of this notification with them.

Further Information:
MHRA St. Johns Wort UK Drug Alert

MHRA St. Johns Wort UK Press Statement.

Note: Products containing St. John’s Wort are medicines and they require an authorisation or a registration from the HPRA in order to be legally supplied to the Irish market.

The HPRA contact for this issue is:

Breda Gleeson
Market Compliance Inspector
Tel: +353 1 634 3331
breda.gleeson@hpra.ie 

Media Queries:
Weber Shandwick PR: (01) 679 8600
Siobhan Molloy / Orla Molloy: 086 817 5066 / 087 770 5108

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