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Home Service Areas National Drug Abuse Control Council Blood pressure and heart medication Valsartan Product Recall

Blood pressure and heart medication Valsartan Product Recall

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Belmopan. July 23, 2018.  The Ministry of Health has been alerted on precautionary product recall from the European Medicines Agency on valsartan, a medication used to treat high blood pressure and heart failure.
The recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. This impurity could cause cancer based on laboratory test results.
Not all valsartan medicines are affected but a few have been identified in Belize.

The Ministry has asked pharmaceutical importers/wholesalers to recall a specific batch series of the Denk Germany and Actavis UK brand of this medication based on our importation data. The Ministry has also asked pharmacies to stop supplying the product and immediately return the stock to their supplier.

At this moment, the European Medicines Agency (EMA) is evaluating potential impact on patients of the exposure to NDMA in valsartan medicines. It has been recommended by EMA that patients continue taking the valsartan medicine until they contact their doctor or pharmacist as there is no immediate risk.

A detail batch list of the recall medication is below.

Product Name                        Manufacturer or Marketing Authorization Holder, Country       Batch Number
Valsar-Denk 80 mg                  Denk Pharma,                                               Germany      19812
Valsar-Denk 80 mg                  Denk Pharma,                                               Germany      20539
Valsar-Denk 160 mg                Denk Pharma,                                               Germany      19619
Valsar-Denk 160 mg                Denk Pharma,                                               Germany      20631
Valsar-Denk 160 mg                Denk Pharma,                                               Germany      21204
Valsar-Denk 160mg                 Denk Pharma,                                               Germany      19755
Valsar-Denk 320 mg                Denk Pharma,                                               Germany      19389
Valsar-Denk 320 mg                Denk Pharma,                                               Germany      20459
Valsar-Denk 320 mg                Denk Pharma,                                               Germany      20460
CoValsar-Denk 160/12.5 mg     Denk Pharma,                                               Germany      19778
CoValsar-Denk 160/12.5 mg     Denk Pharma,                                               Germany      20057
CoValsar-Denk 320/12.5 mg     Denk Pharma,                                               Germany      20354
CoValsar-Denk 80/12.5 mg       Denk Pharma,                                               Germany      20435
CoValsar-Denk 80/12.5 mg       Denk Pharma,                                               Germany      20077
Amva Denk 5/80 mg               Denk Pharma,                                               Germany      99M                                          
Amva Denk 5/160 mg             Denk Pharma,                                               Germany       99K
Amva Denk 10/160 mg           Denk Pharma,                                               Germany       99R
Amva+HCT Denk forte 10/160/25 mg    Denk Pharma,                                  Germany       20547
Amva + HCT Denk mite 5/160/12.5 mg    Denk Pharma,                               Germany       20550
Valsartan 80 mg     Actavis,                                                               United Kingdom     16FA379

Ends
For More Information Contact:
Chrytsal Samouge
Assistant Procurement Manager
Pharmacy Unit
Ministry of Health
Belmopan
822-2325