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IMPORTANT SAFETY WARNING

 From The Health Products Regulatory Authority

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We have been notified by the Health Products Regulatory Authority that a shipment of CE marked Juvéderm ULTRA 4 (hyaluronic acid injection) dermal filler has been seized in another country. The product contains the following error in labelling “Science ofErjuvenation“. The correct label is

“Science of Rejuvenation” based on the real manufacturer’s, Allergan, artwork.  The manufacturer, Allergan, has confirmed that the product pictured is counterfeit.

MANUFACTURER / SUPPLIER                                       HPRA CASE REFERENCE
N/A Counterfeit product- Chinese manufacturer.              MS22683
Supplier- unknown.                                                    

ISSUE
Counterfeit Juvéderm ULTRA 4 dermal filler may be in circulation in Ireland and can be identified by the misspelled word REJUVENATION, which appears on the side of the box as ERJUVENATION, shown above.

ACTION OR RECOMMENDATIONS
The HPRA advises that users:

Do NOT use this counterfeit product on patients or clients;

  1. Contact the HPRA (at the contact details below) immediately if you come across this counterfeit Juvéderm product.
  2. Device packaging, labelling, instructions and product should always be checked before use to determine if anything looks unusual.

The safety, performance and quality of this counterfeit product is not assured.

For a full copy of the safety notice on the HPRA website  CLICK HERE.  

HPRA CONTACT INFORMATION
Health Products Regulatory Authority
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2

Telephone:        +353-1-6764971
Fax:                   +353-1-6344033
E-mail:              devices@hpra.ie
Website:            www.hpra.ie

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