FDA Announces Recall of Some Lots of Blood Pressure Medications
One lot of irbesartan and 7 lots of irbesartan and hydrochlorothiazide (HCTZ) combination tablets distributed by Solco Healthcare, a Prinston Pharmaceutical subsidiary are affected.
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.
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.