FSAI Recall Sona Red Yeast Rice Food Supplement.

FSAI Recall Sona Red Yeast Rice food supplement due to an elevated level of monacolin K.

Alert Notification dated Friday, November 8th 2024.

Category 1: For Action.
Alert Notification: 2024.51.
Product Identification: Sona Red Yeast Rice Standardised Monacolin K; pack size: 60 capsules
Batch Code: All batch codes and best before dates
Country Of Origin: France

Message:

The above implicated Sona Red Yeast Rice food supplement is being recalled due an elevated level of monacolin K.
Recall notices will be displayed at point-of-sale.

Nature Of Danger:

People who consume monacolin K from red yeast rice supplements in an amount greater than 3mg per day may experience several adverse effects. These adverse effects include gastrointestinal disorders e.g. diarrhoea, nausea and abdominal pain, musculoskeletal and connective tissue disorders e.g. myalgia, hepatobiliary disorders and skin and subcutaneous tissue disorders.

Action Required from Manufacturers, wholesalers, distributors, caterers & retailers:

Retailers are requested to remove the implicated product from sale and display recall notices at point-of-sale.

Wholesalers/distributors are requested to contact their affected customers and recall the implicated product and provide a point-of-sale recall notice to their retailer customers.

Consumers are advised not to take the implicated product.