Products to lower blood pressure must be taken off the market
The Heumann Pharma GmbH & Co. Generica KG back once again calls on medical devices to reduce blood pressure, because these were contaminated. In the case of contamination with materials which can be according to the German Federal Institute for drugs and medical devices (BfArM) carcinogenic.
Again now called the blood pressure-lowering drug to be withdrawn from the market because they contain substances, which can be, according to the Federal Institute for drugs and medical devices (BfArM) carcinogenic. According to information from the manufacturer on its home page note that in different batches of the active substance Losartan, an increased value of the contamination with N-Nitroso-N-methyl-4-amino-butyric acid (NMBA). In some batches, even a simultaneous contamination of N-nitroso diethyl amine (NDEA) and NMBA occurred. An appropriate recall for the affected products has been on 07. March 2019 was published in the Pharmaceutical newspaper, the German pharmacist’s newspaper and media.
These products are affected
The products are withdrawn as a precaution in order to avoid negative health effects for users. The following batches are affected by the recall. All batches of Losartan comp. Heumann 100 mg/12.5 mg film-coated Tablets, 28, 56 and 98 film-coated Tablets and all batches starting with the letter B and C of Losartan comp. Heumann 100 mg/25 mg film-coated Tablets, 28, 56 and 98 film-coated Tablets.
Medicines should not be used without consultation discontinued
Customers who use the products mentioned above to reduce your blood pressure, should not now settle, but simply, without a medical consultation, medicines, warns the manufacturer. The resulting health risk is many times higher than the potential risk from the existing contamination.
According to the manufacturer, no acute patients at risk. For further therapy, therefore, a doctor should be consulted, adds the manufacturer on its website. (as)