20 February 2019

Circular # 18 Withdrawal five batch’s from the Pharmaceutical Product (Amubaro)

Reference: CIR-2019-00000053

To all health facilities / all health care practitioners in Dubai's private health sector:

 

Dear colleagues ...

With reference to the above subject, Dubai health authority is alerting all health facilities regarding the circular from MOHAP  That the Japanese company Pfizer has voluntarily withdrawn for five operations of the above product, which contains a compound of the active ingredient (Valsartan & Amlodipine) used in the treatment of high blood pressure, because of the contamination of active substance Valsartan from the source of  the company Mylan Pharmaceuticals in India where found As containing both of the expected carcinogens (N-nitrosodiethylamine (NDEA)) and a small amount of (N-nitrosodiethylamine (NDMA)).
Note that this product is not register in the Drug Control in MOHAP but in order to ensure the safety of patients you were noted.

Important links:

For more information about the alert kindly visit the FDA website :

https://www.fiercepharma.com/manufacturing/pfizer-japan-finds-impurities-its-valsartan-drugs-made-by-mylan

Supporting Documents:

Circular Withdrawal five batchs from the Pharmaceutical Product (Amubaro).pdf:

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