Tuesday, June 18, 2024

Public Advisory on the Voluntary Recall of Losartan Medication


The Ministry of Health & Wellness advises the public of a voluntary recall of Losar-Denk (Losartan) and CoLosar-Denk (Losartan/Hydrochlorothiazide) from the Belize market.
In a letter dated October 4, 2021, Denk Pharma GMBH & Co. KG informed the Ministry of Health & Wellness of an update to perform a voluntary recall of Losar-Denk and CoLosar-Denk from the German market. The recall comes after the European health authorities announced the detection of an impurity called “4-Chlor-Azidomethyltetrazole” in the active Losartan potassium.
The most recent information from European authorities indicates that the impurity can only be formed during the production of the active ingredient Losartan and it has been found in the active ingredient of at least three manufacturers. The presence of the impurity is also above the Threshold of Toxicological Concern (TTC) limit according to the guidelines used to identify potential genotoxic impurities to limit potential carcinogenic risk.
These medications are used to treat high blood pressure and heart failure.
This ministry strongly encourages the public to immediately discontinue the use of this medication, discard any unused medication or return it to their nearest pharmacy. James Brodie & Co. Ltd. is the only importer that is Denk manufacturer registered for importation in Belize. James Brodie & Co. Ltd. has put out a call to customers on their Facebook page to return this medication to their pharmacies.
Denk Pharma GMBH & Co. KG has stated that there is no clinical data available on the impact this impurity can have on humans.

Read more


Please help support Local Journalism in Belize

For the first time in the history of the island's community newspaper, The San Pedro Sun is appealing to their thousands of readers to help support the paper during the COVID-19 pandemic. Since 1991 we have tirelessly provided vital local and national news. Now, more than ever, our community depends on us for trustworthy reporting, but our hard work comes with a cost. We need your support to keep delivering the news you rely on each and every day. Every reader contribution, however big or small, is so valuable. Please support us by making a contribution.

Local News