FDA's Assessment of Currently Marketed ARB drug products

FDA has worked with manufacturers to swiftly remove angiotensin II receptor blocker (ARB) drug products with impurity levels above interim acceptable limits. Those products have been removed from the market and have been posted in our recall lists for ARB products. The information below reflects the status of FDA’s assessment for other ARB drug products that are currently on the market. The assessment is based on the particular batches/lots of drugs tested by FDA, information provided by applicants and active pharmaceutical ingredient (API) suppliers, and other information available to the agency. In general, FDA’s testing of ARBs focused on analyzing API and the highest dosage strength available from firms making drug products for the U.S. market. FDA will update this list as more information becomes available.

In the overall nitrosamine determination column, an indication of “not present” means that FDA has completed the comprehensive assessment noted above. An indication of “TBD” means that one or more parts of our assessment remain incomplete and the product remains acceptable for distribution and for patient use. For the entries denoted with “TBD*,” certain lots of the product did have impurity levels above interim acceptable limits, however they have already been removed from the market. FDA is prioritizing the assessments by those of highest patient need and in response to credible information about nitrosamine contamination.