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PLASMA & BIOTHERAPIES - 24-06-2014

Counterfeit RhoGAM Ultra-Filtered PLUS used for preventing HDN found in India

Johnson & Johnson Limited has identified counterfeit RhoGAM Ultra-Filtered PLUS in the state of West Bengal and Uttar Pradesh in India. This issue does not involve any other product manufactured or distributed by Ortho Clinical Diagnostics or Kedrion Biopharma India Pvt. Ltd.
The health risk of these RhoGAM Ultra-Filtered PLUS injections for HDN patients is estimated to be “very significant”. Obviously, Ortho-Clinical Diagnostics, USA Johnson & Johnson Limited and Kedrion Biopharma India Pvt. Ltd cannot assure the efficacy of counterfeit RhoGAM Ultra-Filtered PLUS injections it did not produce or market. Use of these counterfeit RhoGAM Ultra-Filtered PLUS injections could result in serious injury or death of the child and/or mother. It is noteworthy that laboratory analysis of the counterfeit product has confirmed that it does not contain any active pharmaceutical ingredient (API).

If you receive a product, which you suspect may be a counterfeit, please do not use it and quarantine the same to ensure that it will not be used and immediately report to Mr. Chowdhury either by e-mail (d.chowdhury@kedrioninternational.com) or by a phone call (+91 99307 68909). If you have any questions regarding suspected product(s), please don’t hesitate to contact Mr. Chowdhury.

For further information please download the pdf file attached to this article.

 

For more information please contact: pressoffice@kedrion.com