HMA WGEO – Rapid Alert Form

Counterfeit or illegal product found in the illegal supply chain

Shaded area to be completed by the secretariat

Reference: 0310/003
Date: 09.03.10 / Time: 18:30 / Initials: ST
Please complete sections 1 to 5 providing as much information as possible.
1. REPORTING PERSON
Name: Lex van Nes / Position: Inspector for Healthcare
Organisation: Healthcare Inspectorate the Netherlands
Address: P.O. Box 16119, 2500 BC The Hague, The Netherlands
Telephone No: 0031 70 3406224 / Ext:
e-mail address:
2. PRODUCT DETAILS
Product name: Fruta Planta (herbal product for weight loss)
Manufacturer:Hainan healthy food company Ltd.
Supplier: Guangzhou healthcare Ltd, Guangzhou City, China
Legal status: Banned Counterfeit Unlicensed X Stolen
Dosage form:
Strength:
Batch / lot no: 20090716 Is batch number genuine: Yes X No
If yes to the above, advise batch destination country:
Expiry date: 20110616
Language of packaging: poor English
Date of discovery: 15 February 2010
Details of discovery: Found in fast courier shipment at Rotterdam
Analysed: YESXNO found 16mg SIBUTRAMINE
3. DISTRUBUTION METHOD
Internet: YES / NO X
Internet: / Non internet, advise full details:
URL:
Website address:
Other details:
Currency of payment:
Has product reached patients/consumers? Unknown
4. RISK TO PUBLIC HEALTH
Adverse reactions: YES X / NO
If yes, please advise details: Beside the herbals this product also contains 18 mg SIBUTRAMINE
Although there are No Known reports of adverse incidents, Sibutramine has been withdrawn from the European market on safety grounds.
Medical assessment details:
5. NEED FOR PUBLICITY
Are you making a public statement? YES / NO X
Are you issuing a press release? YES / NO X
Are you recalling product? YES / NO X
If yes to any of the above, when do you intend to take action?
6. PHOTOGRAPH
If possible, please attach a photograph of the product.