HPRA (Ireland) Warning
The HPRA of Ireland released a statement regarding this fake product.
Priority 2 – Warning
HPRA Safety Notice: SN2015(14) Issue Date: 12 June 2015
MANUFACTURER / SUPPLIER HPRA CASE REFERENCE
Falsified- unknown origin. MS24223
‘Derma C’ is being marketed online in Ireland and in other European countries as a ‘Whitening Vitamin C injection’ claiming that it will moisturise skin, fade scars and dark spots, reduce wrinkles, improve skin complexion and elasticity.
The product labelling suggests that the product is a certified medical device manufactured by a company in France. It is not. The product is falsified and is not in compliance with the medical device legislation.
While the HPRA has not received any safety reports relating to this product, as a result of the
above, the product’s safety and performance is not known.
ACTION OR RECOMMENDATIONS
The HPRA advises that users:
1. Do not buy or use DERMA C. If you supply DERMA C, please quarantine the product and contact the HPRA. SUR-F0017-2 2/2
2. If you have used DERMA C or have had ‘treatment’ with DERMA C, stop using it immediately and consult your doctor.
3. Inform the HPRA if you have had any adverse incidents or reactions after having used DERMA C.
General public Beauticians
‘Derma C’ is marketed as an injectable solution of hyaluronic acid for intramuscular or intravenous administration. This falsified product is intended by the manufacturer to “1) Moisture skin, 2) Fade scar and dark spot, 3) Reduce wrinkles, 4) Improve skin complexion, 5) Increase skin elasticity” and as a “Whitening Vitamin C injection”.
The HPRA has recently been made aware that DERMA C is available to purchase on the Irish market. The product packaging claims that the product has been certified and CE-marked as a medical device by a notified body- it has not. The product packaging claims the product is manufactured by a company in France. This company has confirmed to us that they do not manufacture and have never manufactured this product, and that their company name is falsified on the DERMA C product.
The regulatory authorities in each European country are aware of this product and are following up as required.
HPRA CONTACT INFORMATION
When notifying the HPRA of quarantined product, please contact email@example.com
All adverse incidents relating to a medical device should be reported to:
Health Products Regulatory Authority
Kevin O’Malley House
Infarmed (Portugal) Warning
Infarmed Portugal released a statement regarding this fake product below translated from Google Translate:
Information Circular No. 097 / CD / 8.1.7. Date: 03/06/2015
To: General Release
Contact: Drug Information Center and Health Products (CIMI)
Tel 21 798 7373
Fax: 21 111 7552
Medicines Line: 800 222 444
The Swiss customs seized a pack of Derma C (light bulbs), the Mercator Pharmaceutical manufacturer (with address of France), from Malaysia. The Swiss competent authority contacted the notified body (DQS GmbH Medizinprodukte) whose code (0297) stood fixed to the packaging, having informed that the CE 0297 marking was improper. The product in question is probably used as injectable facial filler. In Portugal, were not identified records of product marketing Derma C Mercator Pharmaceutical manufacturer, but, given that there is free movement of products in the European Economic Area and that this product can be purchased over the internet, Infarmed recommends that the devices in question are not purchased or used. The existence of these devices in Portugal should be reported to the Directorate of Infarmed Health Products using the contact details:
tel .: +351 21 798 72 35
fax: +351 21 798 72 81
e-mail: firstname.lastname@example.org .
The Directing Council Helder Mota Filipe
Resellers of Derma C
There are numerous companies that are attempting to sell this and other fake goods online using our company's name, logo and claiming (falsely) that the goods were manufactured in France. From our research, it would appear that the goods are being made in Malaysia and are mostly prevalent in Southeast Asia. We urge local authorities to step in and take action against potentially harmful products where possible, as the importers of this product have not gone through proper registration channels.
Here are the sites we have found attempting to sell our goods: