FDA announces  recall of blood Pressure medications

FDA announces recall of blood Pressure medications

January 19, 2019 284

The FDA is alerting patients and health care professionals to a voluntary recall of certain angiotensin II receptor blockers (ARBs). One lot of irbesartan and 7 lots of irbesartan and hydrochlorothiazide (HCTZ) combination tablets distributed by Solco Healthcare, a Prinston Pharmaceutical subsidiary are affected, according to a statement from the administration.

The recall is due to unacceptable amounts of N-Nitrosodiethylamine (NDEA) in the irbesartan active pharmaceutical ingredient manufactured by Zhejiang Huahai Pharmaceuticals (ZHP) in Linhai, Taizhou Zhejiang, China.

Since July, medication recalls involving multiple companies and products have been announced, due to the presence of NDEA in the active pharmaceutical ingredient (API) supplied by ZHP. Subsequent international investigations expanded to include all manufacturers of API and finished drugs in the ARB class and have resulted in additional recalls of products that were found to contain NDEA, a known animal and suspected human carcinogen.

Solco is only recalling lots of irbesartan-containing medication where NDEA has been detected above the interim limit of 0.088 parts per million. A complete list of the affected products can be viewed on the FDA's website

According to the FDA, the agency is working with manufacturers to reduce and remove nitrosamines from ARBs.

 

Reference

FDA Division of Drug Information. FDA updates on angiotensin II receptor blocker (ARB) recalls including valsartan, losartan and irbesartan. Silver Spring, MD; January 18, 2019: FDA website. http://www.pharmacytimes.com/link/246?rel=0" ?rel=0" .  Accessed January 18, 2019.

 

 

Information source: https://www.pharmacytimes.com/news/fda-announces-recall-of-some-lots-of-blood-pressure-medications

Block ?

If this page is in your subscriptions, then it will be removed. You will not see this page. If you want to unblock a user, go to the settings, the list of blocked users and click unblock

Complain

The user will not know who exactly sent the complaint

Delete Company

The user will not know who exactly sent the complaint

Notifications

You Have 112 readed notifications

CHATS

Select chat category

×