Camber's products, which are packaged into 30-count, 90-count, 500-count and 1,000-count bottles, were distributed nationwide via USA "wholesalers, distributors, retail pharmacies and mail-order pharmacies". The impurity is a known animal and potential human carcinogen. The active ingredient in each came from India-based Hetero Labs Limited.
That impurity is N-nitrosodiethylamine (NDEA), which is classified as a "probable human carcinogen". If patients take an ARB drug product, they should check the list periodically, as information may change.
In the latest such case, Camber Pharmaceuticals on Thursday recalled 87 lots of Losartan Potassium, a prescription drug used to treat high blood pressure and congestive heart failure. Prinston Pharmaceutical identified China's Zhejiang Huahai Pharmaceuticals as the source of NDEA found in its hypertension medication recalled by the company last month.
Amid the recalls of other ARBs, or angiotensin receptor blockers, medications Commissioner Dr. Scott Gottlieb said in the news release that though consumers face few immediate health threats from the recalls, the agency is "deeply concerned" and pursuing an investigation into the possible presence of a third impurity.
In January, the FDA warned of the possibility of additional shortages of hypertension drugs in the United States due to the recalls.
"That said, any presence of such impurities in drug products is not acceptable".
"We are making important strides at understanding how these impurities form and we are continuing to examine if nitrosamine impurities may also arise during the manufacture of other ARB drug products", Gottlieb wrote.
From a community pharmacy perspective, this recall has been hard because many pharmacies don't keep the lot numbers of medications after they're dispensed, Freeman said: "That information is not tracked effectively". Friday, the FDA said it estimated the same for NMBA.
"The FDA is committed to implementing measures to prevent the formation of these impurities during drug manufacturing processes in the future", he added. The company also makes losartan for other Indian drugmakers, including Torrent Pharmaceuticals Ltd. and Macleods Pharmaceuticals Ltd., that has been recalled for containing NDEA.